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

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

Study Overview

• Status: Completed
• Conditions: Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
• Intervention / Treatment: Device: Air-Q Intubation Laryngeal Mask

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 90-419
    • Medical University Lodz
• Switzerland
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institute of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• elective surgery requiring tracheal intubation using an oral tracheal tube
• anticipated extubation in the operating room
• American Society of Anaesthesiologist Physical Status 1-3
• age = 18 years and = 85 years
• oral and written informed consent
• weight = 100kg (according to the product description)
• ability to understand the study information

Exclusion criteria:

• pharyngeal, laryngeal or tracheal pathology, including tracheostomy
• mouth opening < 2.5 cm
• any form of airway infection such as upper-respiratory tract infection, pneumonia or suspected tuberculosis
• any disease that might impair the power of judgement (psychiatric disease, dementia)
• indicated rapid sequence induction which is a standard when high risk for regurgitation and/or aspiration is present
• the subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
• pregnancy
• breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Air-Q Intubation Laryngeal Mask; Patients will be intubated using the Air-Q Laryngeal Mask.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for insertion of the Air-Q laryngeal mask	defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform	300 seconds
Time for insertion of the tube	defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform	300 seconds
First attempt rate and second attempt rate		300 seconds
Time for removal of the Air-Q ILA device after successful intubation		500 seconds
Rate of misplacement of the ILA		300 seconds
Rate of misplacement of the tube		500 seconds
risk factors of insertion failures		500 seconds
Rate of airway injuries		5 hours
Tightness during leak test before relaxation		300 seconds
Tightness during leak test after relaxation		300 seconds
Maximum drop of saturation during airway management		500 seconds
Rate of adverse events	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	5 hours
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Donat R. Spahn, Prof MD, University Hospital Zurich, Institute of Anaesthesiology

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2013-0151