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

NCT ID: NCT01906060

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

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

Conditions

Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Air-Q Intubation Laryngeal Mask

Intervention Type: DEVICE

Patients will be intubated using the Air-Q Laryngeal Mask.

Interventions

Air-Q Intubation Laryngeal Mask

Patients will be intubated using the Air-Q Laryngeal Mask.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donat R. Spahn, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Institute of Anaesthesiology

Locations

Medical University Lodz

Lodz, , Poland

University Hospital Zurich, Institute of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

KantonsSpital Winterthur

Winterthur, , Switzerland

Countries

Poland; Switzerland

Other Identifiers

2013-0151

Identifier Type: -

Identifier Source: org_study_id