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County of Kern Emergency Medical Services Ross Elliott Robert Barnes, M.D. Director Medical Director King Airway Policy June 1, 2010

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Page 1: Emergency Medical Serviceskernpublichealth.com/.../09/supralaryngeal_airway.pdf · 100% oxygen for one minute via bag-valve-mask device between attempts. If attempts at placement

County of Kern

Emergency Medical Services

Ross Elliott Robert Barnes, M.D.

Director Medical Director

King Airway Policy

June 1, 2010

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SUPRALARYNGEAL AIRWAY- KING AIRWAY

I. GENERAL PROVISIONS

A. Supralaryngeal airways are approved for use by all paramedics accredited in Kern County. EMT-I’s who have met the training and certification requirement for the skill and who are employed by EMT-I Advanced Airway Providers are authorized to use this airway device.

B. Supralaryngeal airway procedures in the pre-hospital setting shall only be

preformed using devices approved by the Kern County EMS Department. C. Supralaryngeal airway devices approved for use are the CombiTube and the King

Airway. Refer to the CombiTube Procedures for additional information on the use of the CombiTube.

D. The CombiTube Policies and Procedures shall no longer be used after

December 1, 2010. E. Supralaryngeal airway training conducted after January 1, 2010 shall be only for

the King Airway. The intent is to phase out the use of the CombiTube.

F. This program is implemented and maintained under the authority of the Kern County EMS Department in accordance with California Code of Regulations Title 22 Chapters 2 and 4.

II. OVERVIEW The supralaryngeal airway is a single-use device intended for airway management. It may be used as a rescue airway device when other airway management techniques have failed, or as a primary device when advanced airway management is required in order to provide adequate ventilation. The supralaryngeal airway does not require direct visualization of the airway or significant manipulation of the neck.

The main use for the supralaryngeal airway is in cardiac arrest situations. A supralaryngeal airway may be considered preferable for initial use in patients who are obese or who have short necks, patients with limited neck mobility, or when visualization of the airway is difficult due to blood or emesis in the airway. A paramedic is not required to attempt endotracheal intubation before opting to use of a supralaryngeal airway.

Supralaryngeal airways are not well tolerated in patients with intact gag reflexes and should not be used in patients with perfusing pulses unless all other methods of ventilation have failed.

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Placement of a supralaryngeal may be attempted three times. Ventilations should be interrupted for no more than thirty seconds per attempt. Patients should be ventilated with 100% oxygen for one minute via bag-valve-mask device between attempts. If attempts at placement of an advance airway are unsuccessful after three attempts, BLS airway measures shall be resumed.

The King Airway is approved for use in three sizes and cuff inflation varies by size:

Size 3 – Patients between 4 and 5 fee tall (55 mL air) Size 4 – Patients between 5 and 6 feet tall (70 mL air) Size 5 – Patients over 6 feet tall (80 mL air)

III. INDICATIONS

• Cardiac arrest of any cause • Inability to ventilate non-arrest patient with other BLS maneuvers in a setting in

which endotracheal intubation is unsuccessful or unable to be done

IV. CONTRAINDICATIONS

• Presence of a gag reflex • Caustic ingestion • Known esophageal disease (e.g. cancer, varices, stricture) • Laryngectomy with stoma • Height less than 4 feet

Note: Airway deformity due to prior surgery or trauma may limit the ability to adequately ventilate with a supralaryngeal airway due to the potential for poor seal of the pharyngeal cuff.

V. REQUIRED EQUIPMENT

• Suction • King Airway Kit (size 3, 4, or 5) • Bag-valve-mask • Stethoscope

VI. PROCEDURE FOR USE

1. Assure adequate BLS airway (if possible) 2. Ventilate with 100% oxygen while selecting appropriate size King Airway 3. Test cuff of device by injecting the recommended amount of air into the cuffs.

Fully deflate prior to insertion. 4. Apply water-based lubricant to distal tip and posterior aspect of tube. Avoid

application of lubricant into ventilatory openings.

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5. Position head into the “sniffing position”. Neutral position may be used for suspected cervical spine injury.

6. Hold mouth open and apply chin lift (jaw-thrust for suspected c-spine injury). 7. Insert tube rotated laterally at 45-90 degrees with blue orientation stripe touching

corner of mouth. Advance behind base of tongue. Do not force. 8. Once tube has passed under tongue, rotate tube back to midline with the blue

orientation stripe midline and up towards chin. 9. Advance tube until base connector aligns with teeth or gums. 10. Inflate cuff of tube to required volume, 11. Attach bag-valve-mask and ventilate patient, confirm placement by rise and fall of

the chest and lung sounds. 12. Secure tube and note depth marking of tube. 13. Continue monitoring placement of tube throughout pre-hospital treatment and

transport. 14. Document placement of tube using the Department approved form.

VII. AIRWAY REMOVAL Once a supralaryngeal airway is placed, ideally it should not be removed. Circumstances that necessitate removal of the device may include presence of a gag reflex or inadequate ventilation with the device. Removal of the device may cause vomiting and the following steps should be followed: A. Position patient on side, maintain spinal precautions as needed. B. Have suction available. C. Deflate cuff/cuffs completely and remove smoothly and quickly. D. Reassess airway and breathing to evaluate the need for other adjuncts.

VIII. PATIENT HAND-OFF/TRANSPORT PROCEDURES A. Patients with supralyryngeal airways that have been placed by EMT First

Responders may be released to a paramedic or to an EMT-I with equal training for transport to the hospital.

B. In cases where an EMT-I ambulance is the transporting unit and the staff is not

trained in the use of the device, the first responder must accompany the patient and maintain care responsibility of the airway device until release of the patient at the emergency department. EMT-I transport personnel will maintain responsibility for all other patient treatment and decisions during the transport to the emergency department.

C. If the King Airway is inserted prior to arrival of ALS, the King Airway is to be

left in place if the device is adequately ventilating and protecting the airway.

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Reasons for any case of supralaryngeal airway removal must be documented in the patient care record.

IX. DOCUMENTATION REQUIREMENTS

A. For each case of supralaryngeal airway insertion, or attempted insertion by advanced scope EMT-I providers an “EMT-I Advanced Airway Report Form” shall be submitted to the Kern County EMS Department within forty-eight hours of use. Form is attached.

B. Paramedics or ambulance EMT-Is using supralaryngeal airways shall document

insertion on the patient care record for submission in accordance with the E-PCR Policies and Procedures.

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EMT-I ADVANCED AIRWAY REPORT FORM

Date:__________________ Agency:_________________________________ Unit ID:________________ Call Location____________________________________________________________________________ Call Type_______________________________________________________________________________

TIMES Call Time_______________On Scene ______________________ Patient Contact_____________________ Ambulance On Scene ________________ Transport__________________Completed__________________

PATIENT INFORMATION Name (Last, First)_______________________________________________________________________ Address_______________________________________________________________________________ City/State/Zip___________________________________________________________________________ Age__________ DOB______________ Sex___________ Wt.____________(lbs/kg) Ht.____________ Past Medical History_____________________________________________________________________ Medications_____________________________________________________________________________

NARRATIVE _________________________________________________

_________________________________________________

_________________________________________________

_________________________________________________

VITAL SIGNS

Time B/P Pulse Resp.

INDICATION FOR USE Unresponsive/No gag reflex______ Respiratory or Cardiac Arrest________ Other (please indicate)_______ Number of Attempts______ By____________________________ Size _________ Time_______________ Outcome_______________________________________________________________________________ Transport Ambulance and Unit ID___________________________ Hospital Destination_______________

COMPLETED BY ___________________________________________ __________________________________________Print Name Signature 5

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Appendix A

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EMT-I TRAINING AND ACCREDITATION-KING AIRWAY

I. TRAINING

A. King Airway training shall be provided in accordance with manufacturer guidelines and Department policy and procedures by a person certified in the skill and recommended by their employer.

B. Initial King Airway training shall be a minimum of four hours and shall cover the

King Airway Procedure and the manufacturer training curriculum (Appendix A). C. Each student must pass a twenty question written exam approved by the

Department with a minimum score of eighty percent and successfully demonstrate the skill using the King Airway Skill Sheet with a minimum of seventeen points (Appendix B).

D. Upon successful completion of King Airway training the student shall be issued a

course completion document that includes the following information:

1. Student name 2. Date(s) and hours of training 3. Instructor name and signature

E. Employers conducting King Airway training shall maintain course rosters, written

and skill exams for a period of four years. F. Employers are responsible for ensuring on-gong competency of the employee in

the skill of King Airway.

II. ACCREDITATION A. To be eligible for accreditation the student shall:

1. Provide documentation of employment by an approved Advanced Airway Provider.

2. Provide original course completion documentation for King Airway training to the Department.

3. Provide proof of valid EMT-I certification issued by the Kern County EMS Department.

4. Pay required fees. B. Accreditation shall be continuous unless EMT-I separates from employer or

EMT-I certification lapses. King Airway accreditation expiration dates shall coincide with EMT-I expiration dates.

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Kern County EMS Department

KING AIRWAY SKILL SHEET

Candidate: ______________________________ Examiner: ______________________________ Date: _____________

Required Earned Takes or verbalizes body substance isolation procedures 1 Checks for response 1 Opens the airway manually 1 Checks breathing (Minimum 5 seconds; maximum 10 seconds) 1 Gives 2 breaths (1 second each) 1 Checks carotid pulse (Minimum 5 seconds; maximum 10 seconds) 1 Elevates tongue, inserts simple adjunct [oropharyngeal or nasopharyngeal airway] 1 NOTE: Examiner informs candidate no gag reflex is present and patient accepts adjunct

Attaches oxygen reservoir to bagvalve mask device and connects to high flow oxygen regulator 1 Ventilates patient at a rate of 10-12/minute with appropriate volumes 1 NOTE: After 30 seconds, examiner auscultates and reports breath sounds are present and equal bilaterally and insertion of the King airway is indicated. The examiner must now take over ventilation.

Directs assistant to preoxygenate patient 1 Checks/prepares airway device 1 Lubricates the beveled distal tip and posterior aspect of the tube [may be verbalized] 1 NOTE: Examiner to remove OPA and move out of the way when candidate is prepared to insert device.

Positions head in the “sniffing position” 1 Holds mouth open and applies chin lift 1 Inserts airway, rotating from the lateral to midline position, until proximal opening of gastric access lumen (LTSD model) or the base of connector (LTD model) is aligned with teeth or gums. 1

Inflates cuffs with the minimum volume necessary to seal the airway at the peak ventilatory pressure. 1 Attaches/directs attachment of BVM to the 15 mm connector. 1 While gently bagging patient to assess ventilation, simultaneously withdraws the airway until ventilation is easy and free flowing 1

Confirms placement and ventilation by observing chest rise, auscultation over the epigastrium, and bilaterally over each lung. 1

NOTE: Examiner confirms adequate chest rise, absent sounds over the epigastrium, equal bilateral breath sounds consistent with correct placement.

Secures airway with a commercial device while continuing ventilatory support. 1 Reconfirms airway placement after the device is secured. 1 Continues ventilation with appropriate volumes 1 Passing Score: 17 22

_____ Interrupts ventilations for greater than 30 seconds at any time.

_____ Failure to voice and ultimately provide high oxygen concentrations.

_____ Ventilates patient at a rate greater than 12 breaths per minute.

_____ Failure to provide adequate volumes per breath [maximum 2 errors/minute permissible].

_____ Failure to insert the airway to the proper depth to provide easy and free flowing ventilation.

_____ Failure to inflate cuffs to maintain airway seal.

_____ Failure to remove the syringe immediately after inflation of cuffs.

_____ Failure to confirm proper placement by observing chest rise, epigastric and bilateral lung auscultation.

_____ Inserts any adjunct in a manner dangerous to patient.

4/09

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Appendix B

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I n s e r v i c e P r o g r a m

04.17.08

*KING LT-DTM and KING LTS-DTM

KLTD/KLTSDDi spo sab l e Sup ra l a r yngea l A i rway s *

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Page 2 04.17.08

KLTD/KLTSD Disposable Supralaryngeal Airways

The KLTD/KLTSD are disposable supralaryngeal airways createdas alternatives to tracheal intubation or mask ventilation. TheKLTD/KLTSD are designed for positive pressure ventilation as wellas for spontaneously breathing patients, thereby allowing maximum versatility as airway management tools. TheKLTD/KLTSD consistently achieve a ventilatory seal over 30 cmH2O. They are easy to insert and result in minimal airway trauma. The KLTD/KLTSD are 100% latex free and aredesigned for single patient use. The KING LTS-D offers theunique ability to pass a gastric tube through a second channel ofthe airway into the stomach.

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PROXIMAL CUFFStabilizes KING LT-Dand seals the oropharynx.

SINGLE VALVE /PILOTBALLOONInflates both the proximaland distal cuffs.

TWO VENTILATIONOUTLETSIn front of the larynx for efficient ventilation and allows passage of fiberoptic bronchoscope or tube exchange catheter.

BILATERAL EYELETSAdditional eyelets to supplement ventilation.

LATEX FREE ANDSINGLE PATIENT USE

ORIENTATION / X-RAY LINE

DISTAL CUFFBlocks entry of esophagus. Reduces the possibility of gastric insufflation.

CM DEPTH MARKINGS

KING LT-D Design

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PROXIMAL OPENING OFGASTRIC ACCESS LUMEN

BILATERALVENTILATION EYELETS

DISTAL TIP AND CUFFAnatomically shaped to assist in passagebehind the larynx and into the normally collapsed esophagus.

PRIMARY VENTILATORYOPENING

MULTIPLE DISTALVENTILATORYOPENINGS

DISTAL OPENINGOF GASTRICACCESS LUMEN

DESIGN FEATURES

EXCLUSIVE TO THE

KING LTS-D.

KING LTS-D Design

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Page 5

KLTD/KLTSD EMS Kits

04.17.08

Each EMS Kit Includes:� KLTD or KLTSD� Syringe� Lubricant� Instructions for Use

*KING LT-D EMS Kits pictured

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Page 6 04.17.08

Proximal Cuff Inflates at the base of the tongue. Isolates the laryngopharynx from the oropharynx and nasopharynx.

Distal CuffInflates in the esophagus. Isolates thelaryngopharynx from the esophagus.

Esophagus

Epiglottis

Hyoid Bone

Trachea

Vocal Cords Hard Palate

Soft Palate

Gas Flow

Placement Diagram

Single InflationValve

cm Depth Markings

Primary Ventilatory Outlets Additional Side Eyelets

Distance from Distal Opening

KING LTS-D

KING LT-D

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Page 7 04.17.08

The design of the KLTD & KLTSD offers:

1. The ability to provide positive pressure

ventilation as well as spontaneous breathing.

2. A seal pressure over 30 cm H2O.

3. Ease of insertion.

4. Low incidences of sore throat and trauma.

5. Minimizes gastric insufflation.

6. KLTSD allows easy passing of a gastric tube

through the gastric access lumen into the stomach.

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KING LT-D Design

Page 8 04.17.08

Soft, pliable cuffs

Soft, flexible beveled tip inside

distal cuff

Ramp directstube exchangecatheter out

ventilation opening

Tube

Exchange

Catheter

Distal

Ventilatory

Opening

Two main ventilation outlets and

bi-lateral eyes for additional

ventilation

Ventilation

Outlets

Lateral Eyes

(Three on each

side of tube)

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KING LTS-D Design

Multiple ventilation outlets and

bilateral eyelets for best

ventilation

Page 9 04.17.08

Distal tip and cuffflattened for more

anatomical fit behind larynx

Ramp directstube exchange

catheter out Primary Ventilatory Opening

Tube

Exchange

Catheter

Distal

Ventilatory

Openings

Ventilation

Outlets Bilateral

Eyelets

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Curved Design

Page 10 04.17.08

The KLTD/KLTSD supraglottic

airways are designed with a

straightened, beveled distal tip

that assists in directing the

airways posterior to the larynx

and into the upper esophagus.

Due to this unique configura-

tion, there is minimal risk of

either device entering the

trachea.19

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ContraindicationsResponsive patients with an intact gag reflex.Patients with known esophageal disease.Patients who have ingested caustic substances.

The KLTD/KLTSD is intended for airway management inpatients for controlled (over 30 cm H2O) or spontaneous ventilation. Also indicated for difficult andemergent airway cases and well suited for ambulatoryand office-based anesthesia.

Page 11

Indications of the KLTD/KLTSD

04.17.08

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Sizing & Information

Cuff PressureGauge

ITEM #KLT 900

SIZE 2 2.5 3 4 5

CONNECTOR COLOR Green Orange Yellow Red Purple

PATIENT CRITERIA

35-45 inches

(90-115 cm)

or 12-25 kg

41-51 inches

(105-130 cm)

or 25-35 kg

4-5 feet

(122-155 cm)

5-6 feet

(155-180 cm)

greater than

6 feet

(>180 cm)

CUFF PRESSURE 60 cm H2O 60 cm H2O 60 cm H2O 60 cm H2O 60 cm H2O

11 mm/7.5 mm

n/a

11 mm/7.5 mm

n/a

14 mm/10 mm

18 mm/10 mm

14 mm/10 mm

18 mm/10 mm

14 mm/10 mm

18 mm/10 mm

25-35 ml

n/a

30-40 ml

n/a

45-60 ml

40-55 ml

60-80 ml

50-70 ml

70-90 ml

60-80 ml

KING LTS-D is not available in size 2 and 2.5

KLTD: Maximum Size Fiberoptic Bronchoscope: 7.0 mm O.D. (size 3, 4, 5) and 4.7 (size 2, 2.5); Maximum Size Tube Exchange Catheter: 19 Fr (size 3, 4, 5) and 14 Fr (size 2, 2.5); Minimum Mouth Opening: 16 mm (size 3, 4, 5) and 12 mm (size 2, 2.5)

KLTSD: *Ventilation Lumen is not round, but is equivalent to a 10 mm I.D. tube; Maximum Size Tube Exchange Catheter: 19 Fr; Maximum Size Fiberoptic Bronchoscope: 6 mm OD; Minimum Mouth Opening: 20 mm

KLTD KLTD202 KLTD2025 KLTD203 KLTD204 KLTD205

KLTD EMS KLTD212 KLTD2125 KLTD213 KLTD214 KLTD215

KLTSD n/a n/a KLTSD403 KLTSD404 KLTSD405

KLTSD EMS n/a n/a KLTSD413 KLTSD414 KLTSD415

EMS kits are non-sterile and contain a KING LT-D or KING LTS-D, syringe for cuff inflation, lubricant, and abbreviated instructions for use.

KLTD O.D./I.D.KLTSD O.D./I.D.*

KLTD CUFF VOLUME

KLTSD CUFF VOLUME

PRODUCT INFORMATION

SIZING INFORMATION

KING LTS-D

KING LT-D

Size 2 Size 2.5 Size 3 Size 4 Size 5Product

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KLTD/KLTSD Insertion Guide,PreparationChoose correct size based on patient’s height(weight can also be used for size 2 and 2.5):

35-45 in (90-115 cm) Size 2*or 12-25 kg in weight

41-51 in (105-130 cm) Size 2.5*or 25-35 kg in weight

4 to 5 ft (122-155 cm) Size 3

5 to 6 ft (155-180 cm) Size 4

> than 6 ft (>180 cm) Size 5

Test cuff inflation system for air leak.

Apply water-soluble lubricant to the distal tip.

* Size 2 and 2.5 only available in KING LT-D. 22

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Insertion Guide, Step 1

Page 14 04.17.08

Blue Orientation Line

Hold the KLTD/KLTSDat the connector withdominant hand.

With non-dominant hand,hold mouth open andapply chin lift, unless contraindicated by C-spineprecautions or patient position.

Using a lateral approach, introduce tip into cornerof mouth.

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Page 15

Insertion Guide, Step 2

04.17.08

Advance the tip behind the base of the tongue while rotating tube back to midline, so that the blue orientation line faces the chin of the patient.

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Page 16

Insertion Guide, Step 3

04.17.08

Without exerting excessive force, advancetube until base of connector is aligned with teeth or gums.

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Page 17 04.17.08

Inflate cuffs to 60 cm H2O or to “just seal” volume.

EMS Kit: Inflate cuffs using themaximum volume of the syringeprovided.

Typical inflation volumes are asfollows:

Insertion Guide, Step 4

KING LT-DSize #2 25-35 mlSize #2.5 30-40 mlSize #3 45-60 mlSize #4 60-80 mlSize #5 70-90 ml

KING LTS-DSize #3 40-55 mlSize #4 50-70 mlSize #5 60-80 ml

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Attach the breathing circuit/resuscitator bag to the KLTD/KLTSD.

While gently bagging the patient, withdraw the tube until ventilation is easy and free flowing (large tidal volume with minimal airway pressure).

Insertion Guide, Step 5

Page 18 04.17.08

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Page 19 04.17.08

If necessary, add additionalvolume to cuffs to maximize seal of the airway.

Insertion Guide, Step 6

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Insertion Guide, Step 7

Lubricate gastric tube (up to an 18 Fr) prior to inserting into the KLTSD’s gastric access lumen.

When utilizing the KING LTS-D’s gastric accesslumen:

Page 20 04.17.08

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Page 21 04.17.08

User Tips1.The key to insertion is to get the distal tip of the KLTD/KLTSD around the

corner in the posterior pharynx, under the base of the tongue. Experience has indicated that the lateral approach, in conjunction with a chin lift, facilitates the placement of the KLTD/KLTSD. Alternatively, a laryngoscopeor tongue depressor can be used to lift the tongue anteriorly to allow easy advancement of the KLTD/KLTSD into position.

2.Insertion can also be accomplished via a midline approach by applying a chin lift and sliding the distal tip along the palate and into position in the hypopharynx. In this instance, head extension may also be helpful.

3.As the KLTD/KLTSD is advanced around the corner in the posterior pharynx, it is important that the tip of the device be maintained at the midline. If the tip is placed or deflected laterally, it may enter into the piriform fossa and the tube will appear to bounce back upon full insertion and release. Keeping the tip at the midline assures that the distal tip is properly placed in the hypopharynx/upper esophagus.

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Page 22 04.17.08

4.Depth of insertion is key to providing a patent airway. Ventilatory openings of the KLTD/KLTSD must align with the laryngeal inlet for adequate oxygenation/ventilation. Experience has indicated that initially placing the KLTD/KLTSD deeper (base of connector is aligned with teeth or gums), inflating the cuffs, and retracting until ventilation becomes easy and free flowing is preferred because:

� It ensures that the distal tip has not been placed laterally in the piriform fossa (see item #3).

� With a deeper initial insertion, only withdrawal is required to realize a patent airway. A shallow insertion will require deflation of cuffs to advance the tube deeper.

� As the KLTD/KLTSD is withdrawn, the initial ventilation opening exposed to/aligned with the laryngeal inlet is the proximal opening. Since the proximal opening is closest to and is partially surrounded by the proximal cuff, airway obstruction is less likely.

� Withdrawal of the KLTD/KLTSD with the cuffs inflated results in a retraction of tissue away from the laryngeal inlet, thereby encouraging a patent airway.

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Page 23 04.17.08

epiglottis

Epiglottis obstructing distal ventilatory

opening

KING LT-D advanced torelieve obstruction

epiglottis

5.During spontaneous ventilation, the epiglottis or other tissue can bedrawn into the distal ventilatory opening, resulting in obstruction. Advancing the KLTD/KLTSD 1-2 cm or initiating deeper placement normally eliminates this obstruction.

6.Ensure that the cuffs are not over inflated. Cuff pressure should be adjusted to 60 cm H2O or to “just seal” volume.

7.Removal of the KLTD/KLTSD is well tolerated until the return of protective reflexes. For later removal, it may be helpful to remove some air from the cuffs to reduce the stimulus during wake-up.

8.KING LTS-D: Lubricate the gastric tube prior to inserting into gastric access lumen.

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KLTD/KLTSD RemovalSuction above cuffs in the oral cavity, if indicated.

FULLY deflate both cuffs before removal of the KLTD/KLTSD.Note: Depending on the volume used for cuff inflation, it may require more than one filling of the syringe to achieve complete evacuation of the KLTD/KLTSD cuffs.

Remove the KLTD/KLTSD when protective reflexes have returned.

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1. Preparation:� Use only water soluble lubricant. Do not apply lubricant near ventilatory openings.

2. Induction:� Patient should be “deep enough”, do NOT insert the KLTD/KLTSD if the patient is

swallowing, retching, moving or gagging.

3. Insertion:� Hold the KLTD/KLTSD with the dominant hand at the proximal end (connector)

such that insertion will be accomplished in a single, continuous motion.� Use the lateral approach with chin lift.� Insert the KLTD/KLTSD until the base of the connector is aligned with teeth or gums.� The KLTD/KLTSD should not “bounce out” after release.

4. Inflation:� Using a pressure gauge: 60 cm H2O. � Using a syringe: just seal (average volumes: KLTD: Size #2, 25-35 ml; Size #2.5, 30-40 ml;

Size #3, 45-60 ml; Size #4, 60-80 ml; Size #5, 70-90 ml). KLTSD: Size #3, 40-55 ml; Size #4, 50-70 ml; Size #5, 60-80 ml.

� Check that the blue (pharyngeal) cuff is not visible in the oropharynx.

5. Final Positioning:� Withdraw the KLTD/KLTSD until ventilation is optimized.� Readjust cuff inflation.

6. Taping:� Disconnect the circuit and aggressively tape the KLTD/KLTSD in the

midline to the maxilla.� For the KLTSD, avoid taping over the opening to the gastric access lumen.

Critical Steps

04.17.08

Goals:� Seal pressure:

>30 cm H2O� Ventilation parameters:

appropriate tidal volumes (8-10 ml/kg)with low airway pressures (15-25 cmH2O)

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04.17.08

The KLTD/KLTSD are versatile airway tools offering:

1. The ability to provide positive pressure ventilation as well as spontaneous breathing.

2. A seal pressure over 30 cm H2O.

3. Ease of insertion.

4. Low incidences of sore throat and trauma.

5. Minimizes gastric insufflation.

6. The KING LTS-D allows easy passing of agastric tube through the gastric access lumen into the stomach.

Conclusion

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Page 27

Questions & Answers

04.17.08

Q. What are the general indications for use?

A. The KLTD/KLTSD can be used in:

� Elective cases involving spontaneous or positive pressure ventilation

� Ambulatory and office-based anesthesia

� Difficult airway cases� Emergency airway

management � Prehospital Use

Q. What are the possible cases for the KLTD/KLTSD to be used?

A. The KLTD/KLTSD is

suitable for the cases

listed at the right.

General & Breast Biopsy Neurosurgery Ventriculorperitoneal shunt insertion

Abdominal Colectomy Stereotactic biopsy

Colonoscopy Drainage of subdural hematoma

Femoral/umbilical hernias Orthopedic Amputation

Hemiocolectomy Arthoscopy

Hemorrhoidectomy Carpal tunnel release

Inguinal herniorraphy Hand and foot procedures

Laparoscopic cholecystectomy Podiatry

Laparoscopic herniorraphy Shoulder reconstruction

Laparotomy Tendon repair

Mastectomy Total joint replacement

Pelvic laparoscopy Outside OR Electroconvulsive therapy

Rectal surgery Endoscopic procedures

Ventral hernia repair Medical imaging

Eyes, ENT Eye lid repair Interventional radiology

Strabismus Cardioversion

Middle ear surgery Plastics Cosmetic

Myringotomy Face lift

Plastic procedures Mastopexy

Sinus surgery Skin grafts

Gynecologic D & C Urologic Cystoscopy

Gynecologic laparoscopy Open prostatectomy

Hysteroscopy Orchiopexy

Laparoscopic myomectomy TURF

Myomectomy Vascular Carotid endarterectomy

Total abdominal hysterectomy Fem-pop bypass vein stripping

Tubal ligation

Vaginal hysterectomy

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Page 28 04.17.08

Q. Can the KLTD/KLTSD be used for positive pressure ventilation?A. The KLTD/KLTSD was designed for use with positive pressure ventilation as well as spontaneously breathing

patients. It consistently achieves a ventilatory seal over 30 cm H2O.

Q. Does the KLTD/KLTSD provide protection from aspiration?A. Studies specifically evaluating the KLTD/KLTSD for aspiration protection have not been performed; such studies

are not reasonable to perform on human subjects. However, the inflated distal cuff does represent a physical obstruction in the esophagus and has been shown to protect against gastric insufflation at pressures greater than 30 cm H2O. This would suggest that the distal cuff should provide some resistance to rising gastric contents.

Q. Is there an optimal head position for insertion?A. Sniffing position is optimal, however insertion can also be accomplished with the head in the neutral position.

For obese patients, elevation of the shoulders and upper back should be considered.

Q. What sizes are available?A. The KLTD is available in size 2, 2.5, 3, 4, & 5 and can be used with patients 35 inches (90 cm) and taller.

The KLTSD is available in size 3, 4, & 5 and can be used with patients 4 feet (122 cm) and taller. Size 2 and 2.5 areonly available in KLTD.

Q. How do I determine what size to use?A. Pediatric sizes are based on the patient’s height or weight and adult sizes are based on the patient's height.

Size 2: 35-45 in (90-115 cm) in height or 12-25 kg in weight; Size 2.5: 41-51 in (105-130 cm) in height or 25-35 kg in weight; Size 3: 4 to 5 ft (122-155 cm); Size 4: 5 to 6 ft (155-180 cm); Size 5: > than 6 ft (>180 cm).

Q. What size gastric tube can be inserted through the gastric access lumen of the KING LTS-D?A. Up to an 18 Fr gastric tube can be inserted through the gastric access lumen of the KLTSD.

Note: Lubricating the gastric tube greatly facilitates its passage.

Q. What is the best way to hold the KLTD/KLTSD during insertion?A. By grasping the connector, insertion can be easily accomplished with a single motion. 37

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Page 29 04.17.08

Q. How do I insert the KLTD/KLTSD?A. With the dominant hand holding the KLTD/KLTSD, apply chin lift with non-dominant hand. This technique is

similar to intubation where a laryngoscope provides the chin lift and an endotracheal tube is inserted laterally.

Q. What is the correct depth of insertion?A. While each patient is unique and therefore requires clinical judgment, feedback has indicated that initially

placing the product with connector to the teeth, inflating the cuffs, and withdrawing the KLTD/KLTSD until ventilation is optimized results in the best depth of insertion.

Q. Can a laryngoscope be used?A. Although not routinely needed, a laryngoscope may be helpful for the inexperienced user or for difficult

insertions.

Q. What volume of air is needed to properly inflate the cuffs?A. Always use the least amount of air needed to create a seal at the desired ventilatory pressures. The average

inflation volume for each size is as follows: KLTD: Size 2 = 30 ml, 2.5 = 35 ml, Size 3 = 50 ml, Size 4 = 70 ml,Size 5 = 80 ml; KLTSD: Size 3 = 47 ml, Size 4 = 60 ml, Size 5 = 70 ml. Note that the inflation volume differs for each patient. Typical volumes will be within 10 ml of the average listed for each size. Preferrably, cuffs should be inflated to a pressure of 60 cm H2O instead of inflating with a set volume. Sizes 2 and 2.5 are only available in KLTD.

Q. What pressure do I inflate the cuffs to?A. Using a pressure gauge similar to the KLT 900, inflate all sizes of the KLTD/KLTSD to 60 cm H2O.

Q. What is the reference point for the centimeter depth markings on the KLTD/KLTSD?A. The cm markings indicate the distance from the distal ventilatory opening. Like the cm markings found on a

tracheal tube, KLTD/KLTSD cm markings serve as a visual reference after placement and can be used to document insertion depth.

Q. How long can the KLTD/KLTSD be left in place?A. The KLTD/KLTSD has been used in routine procedures up to 8 hours. For longer procedures it is important to

monitor and limit cuff pressure to 60 cm H2O or less, or when N2O is used. 38

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04.17.08Page 30

Q. If I need to mechanically ventilate my patient, do I need to replace the KLTD/KLTSD with a tracheal tube as I would with an LMA type device?

A. Due to the improved ventilatory seal of the KLTD/KLTSD compared to other supraglottic airways, the need to switch to a tracheal tube should be less frequent with the KLTD/KLTSD than with LMA type devices.

Q. How do I exchange the KING LT-D for a tracheal tube?A. If tracheal intubation is indicated, a lubricated size 6.0 standard tracheal tube can be inserted directly through

the KLTD (sizes 3-5) with tracheal placement confirmed fiberoptically. Experience has indicated that you may need to withdraw the KLTD slightly to facilitate alignment of the distal ventilatory opening with the laryngeal inlet, thereby allowing advancement of the tracheal tube into the trachea. Once the tracheal tube has been installed in the trachea, the KLTD can remain in place with the cuffs deflated, or the entire assembly can be exchanged for another tracheal tube using a tube exchange catheter.

Q. Can a tube exchange catheter be used to exchange the KING LT-D for a tracheal tube?A. Yes; this is actually the preferred method when using the KLTSD (see below).

Q. What method is used to exchange a tracheal tube for a KING LTS-D?A. The technique involves the use of a tube exchange catheter inserted through the KLTSD ventilation channel.

For best results, visualization of tube exchange catheter placement into the trachea is recommended. This can be accomplished by direct laryngoscopy or by using a fiberoptic bronchoscope. The Aintree Intubation Catheter (Cook Critical Care) allows a pediatric fiberoptic bronchoscope to be placed inside the exchange catheter. Note that lubrication of the exchange catheter is indicated to facilitate in passing it through the KLTSD.

Q. How do I clean the KLTD/KLTSD?A. The KLTD/KLTSD are sold as single patient use products (packaged sterile for in-hopsital use) and should not

be reused. If you are interested in the reusable KING LT, contact your sales representative or King Systems at 800-642-5464.

Q. Does King Systems offer a reusable version of the KLTD?A. Yes, in fact the reusable KING LT is available worldwide and has been used in over 2 million cases. A

reusable version of the KLTSD is not available in the United States or Canada. 39

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Page 31 04.17.08

Overall Success"50 patients: Insertion was determined to be easy and a patent airway was achieved in all patients." Hagberg C et at. An Evaluation of the Insertion andFunction of a New Supraglottic Airway Device, the KING LT™, During Spontaneous Ventilation. Anesth Analg 2006; 102:621–5.

175 patients: Successful mechanical ventilation in 169 patients (96.6%); unacceptable in 3 patients due to airway pressures above 40cm H2O; 3 due tounacceptable ventilation. Gaitini L et al. An Evaluation of the Laryngeal Tube During General Anesthesia Using Mechanical Ventilation. Anesth Analg 2003;96:1750-5.

25 patients: LT inserted successfully on the first attempt in all cases. Ocker H et al. A Comparison of the Laryngeal Tube with the Laryngeal Mask AirwayDuring Routine Surgical Procedures. Anesth Analg 2002; 95:1094-7.

30 patients: In all cases, the LT was inserted successfully on the first attempt. Dorges V et al. The Laryngeal Tube: A New Simple Airway Device. AnesthAnalg 2000; 90:1220-2.

60 patients: In all patients the LT was inserted successfully on the first attempt. Agro F et al. Preliminary Results Using the Laryngeal Tube for SupraglotticVentilation. Am J Emerg Med 2002; Jan.

Difficult Airway / Emergency Airway UseIn a large regional air medical service, the KING LT-D was used as an alternative airway after three unsuccessful ETI attempts or in situations of anticipat-ed ETI difficulty. Most were major trauma patients with facial injuries or blood and secretions in the airway. All 26 patients managed with the KING LT-Dwere successfully ventilated as confirmed by continuous waveform end tidal capnography. Guyette F. King Airway Use by Air Medical Providers. PrehospitalEmergency Care; 2007, 11:1-4.

A significant time difference and simplicity exists in placing the laryngeal tube (LT), making it an attractive device for expeditious airway management.The LT’s uncomplicated design allows for successful use by a variety of healthcare providers. Russi C et al. The laryngeal tube device: a simple and timelyadjunct to airway management. American Journal of Emergency Medicine; 2007, 25:263–267.

Laryngeal Tube was successfully used in three patients in whom insertion of the laryngeal mask had failed. Asai T et al. Use of the laryngeal tube after failedinsertion of a laryngeal mask airway. Anaesthesia 2005; 60:825-826.

Laryngeal Tube was inserted easily and adequate ventilation was obtained after failed nasotracheal fiberoptic intubation and failed LMA insertion. Asai T.Use of the laryngeal tube for difficult fibreoptic tracheal intubation. Anaesthesia 2005; 60:826.

The KING LT-D provides a secure, non-intubating emergency airway when direct laryngoscopy is not feasible. Fowler R. KING LT-D to the Rescue. JEMS2005; 07:90-92.

In an out-of-hospital emergency setting, the LT was placed in 30 patients in cardiac arrest by minimally trained nurses. Ventilation was adequate in 80%of the cases; no episodes of regurgitation or vomiting occurred and no blood staining on the LT was observed. Kette F et al. The use of laryngeal tube bynurses in out-of-hospital emergencies: Preliminary experience. Resuscitation 2005; 66:21-25.

Clinical Studies

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Page 32 04.17.08

EMT students found that they were able to initiate ventilation more rapidly but with equal effectiveness compared to tracheal intubation; compared toBMV, they were able to provide better minute ventilation with the KING LT. Kurola J et al. Airway management in cardiac arrest-comparison of the laryngealtube, tracheal intubation and bag-valve mask ventilation in emergency medical training. Resuscitation 2004; 61:149-153.

Case report: The LT provided adequate ventilation in two difficult airway management cases. Matioc A et al. Use of the Laryngeal TubeTM in two unexpecteddifficult airway situations: lingual tonsillar hyperplasia and morbid obesity. Canadian Journal of Anesthesia 2004; 51:1018-1021.

Case report: With tracheal intubation not possible, LT was inserted successfully on first attempt. Ventilation and oxygenation were possible through theLT at all times. Genzwuerker H et al. Use of the laryngeal tube for out-of-hospital resuscitation. Resuscitation 2002; 52:221-4.

26 of 28 students stated that insertion with LT was easier than LMA. Tidal volume was significantly greater and the incidence of gastric insufflation wassignificantly lower with the LT. Asai T et al. Efficacy of the laryngeal tube by inexperienced personnel. Resusciation 2002; 55:171-5.

LT placed in a 57 yr old female with acute progressive quadriplegia due to subluxation at the atlanto-axial level. Reinforced nsaotracheal tube was subse-quently placed fiberoptically along side the LT. Asai T. Use of the Laryngeal Tube in a patient with an unstable neck. Can J Anaesth 2002; 49(6): 642-3.

LT has a potential role in CPR especially in elderly patients without teeth. Asai T et al. Use of the laryngeal tube in patients without teeth. Resuscitation 2001;51:213-214.

Ventilatory Seal In 22 patients, the mean leak pressure was significantly greater for LT vs. LMA; gastric insufflation did not occur with the LT, but was noted in 3 patientswith the LMA. Asai T et al. The laryngeal tube compared with the laryngeal mask: insertion, gas leak pressure and gastric insufflation. Br J Anaesth 2002; 89(5):729-32.

In a study of 50 patients, the airway leak pressure observed with the LT was 36cm H2O vs. 22cm H2O with the LMA. Ocker H et al. A Comparison of theLaryngeal Tube with the Laryngeal Mask Airway During Routine Surgical Procedures. Anesth Analg 2002; 95:1094-7.

In 30 patients, airway pressures of 40cm H2O possible without gastric inflation. Dorges V et al. The Laryngeal Tube: A New Simple Airway Device. AnesthAnalg 2000; 90:1220-2.

Delivered tidal volume of .486L with LT compared to .500L for endotracheal tube; auscultation over the epigastrium during lung inflation with the LTshowed no sign of gastric insufflation. Vollmer T et al. Fibreoptic control of the laryngeal tube position. Eur J Anaesthesiol 2002; 19:306-7.

Low Incidence of Complications50 patients: The unique design of the KING LT allows for ease of placement and advancement, minimizes the risk of aspiration, and has acceptable ratesof both intraoperative and postoperative complications. Hagberg C et al. An Evaluation of the Insertion and Function of a New Supraglottic Airway Device, theKING LT, During Spontaneous Ventilation. Anesth Analg 2006; 102:621–5.

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15011 Herriman Boulevard, Noblesville, IN 46060

CAUTION: Federal law restricts this device to sale by or on the order of a physician. Made in the U.S.A.KING LT-DTM and KING LTS-DTM are trademarks of King Systems Corporation. U.S. Patent: 5,819,733. © 2008 King Systems Corporation

04/08

PLFM-48

LIT 48

Page 33 04.17.08

In 60 patients, no adverse airway events occurred and no gastric inflation was detected. After 24 hrs no patient reported sore throat, mouth pain or dyspa-hagia. Agro F et al. Preliminary Results Using the Laryngeal Tube for Supraglottic Ventilation. Am J Emerg Med 2002; Jan.

No blood was visualized in 171 of 175 cases; grade 1 upper airway trauma in 4 patients. Sore throat (12 cases) disappeared within 24 hrs (no treatmentrequired); no complaint of hoarseness occurred. Gastric insufflation was not detected by epigastric auscultation in any patient. Gaitini L et al. AnEvaluation of the Laryngeal Tube During General Anesthesia Using Mechanical Ventilation. Anesth Analg 2003; 96:1750-5.

An in vitro study determined that the storage capacity (regurgitated volume before aspiration occurs) is 3.5ml for the LMA vs. 15ml with the LT. Miller D etal. Storage Capacities of th Laryngeal Mask and Laryngeal Tube Compared and Their Relevance to Aspiration Risk During Positive Pressure Ventilation. AnesthAnalg 2003; 96:1821-2.

Likelihood of LT Tip Entering Trachea In 500 attempts in a mannequin, no inadvertent tracheal intubation occurred. Even using a laryngoscope, the LT could not be placed in the trachea due tothe form and length of the tube. Genzwuerker H et al. The Laryngeal Tube: A New Adjunct for Airway Management. Prehosp Emerg Care 2000; 4(2):168-72.

Tracheal Intubation After Placement of the KING LTFiberoptic placement of a tube exchange catheter through the LT allowed successful switch to tracheal intubation in 9 of 10 patients. Genzwueker H et al.Fibreoptic tracheal intubation after placement of the laryngeal tube. Br J Anaesth 2002; 89(5):733-8.

After placement of the LT in a 24 yr old male with multiple fractures of the jaw, fiberoptic nasotracheal intubation along side the LT was accomplished.Asai T et al. Use of the laryngeal tube for nasotracheal intubation. Br J Anaesth 2001; 87(1).

www.kingsystems.comPhone: 317-776-6823

Toll Free: 800-642-5464 Fax: 317-776-6827

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