Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial

Phase 4

Completed

• Conditions: Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
• Interventions: Device: Air-Q Intubation Laryngeal Mask

• Registration Number: NCT01906060
• Lead Sponsor: University of Zurich

Brief Summary

The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%.

Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%.

This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA.

* Trial with medical device

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-23
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Air-Q Intubation Laryngeal Mask	Air-Q Intubation Laryngeal Mask	Patients will be intubated using the Air-Q Intubation Laryngeal Mask and subsequently intubated with a commercially available endotracheal tube via the Intubation Laryngeal Mask.

Primary Outcome Measures

Name	Time	Method
Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.	300 seconds	Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts.

Secondary Outcome Measures

Name	Time	Method
Tightness during leak test after relaxation	300 seconds
Rate of misplacement of the ILA	300 seconds
Rate of misplacement of the tube	500 seconds
Rate of airway injuries	5 hours
Tightness during leak test before relaxation	300 seconds
Time for insertion of the Air-Q laryngeal mask	300 seconds	defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform
Time for insertion of the tube	300 seconds	defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform
First attempt rate and second attempt rate	300 seconds
Time for removal of the Air-Q ILA device after successful intubation	500 seconds
risk factors of insertion failures	500 seconds
Maximum drop of saturation during airway management	500 seconds
Rate of adverse events	5 hours	including, but not limited to suspicion of aspiration or regurgitation (gastric fluid in the ventilation tube or hypopharynx), bronchospasm, airway obstruction, coughing, dental-, tongue-, lip- pharyngeal or laryngeal trauma
Rate of necessity of alternative airway device	500 seconds
Rate of blood stained devices after removal of the ILA	500 seconds
Postoperative coughing after 2 hours and the next morning	24 hours
Postoperative hoarseness after 2 hours and the next morning	24 hours

Trial Locations

Locations (3)

Medical University Lodz; 🇵🇱 Lodz, Poland

KantonsSpital Winterthur; 🇨🇭 Winterthur, Switzerland

University Hospital Zurich, Institute of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland