First Attempt Intubation Rate With Airtraq vs Macintosh Direct Laryngoscope (FAIRAiM)

A Randomized Controlled Trial to Compare the First-pass Intubation Success of the Airtraq Laryngoscope Versus the Macintosh Direct Laryngoscope in Patients Requiring General Anaesthesia for Elective Operation.

In recent decades, numerous videolaryngoscopes have been introduced to facilitate tracheal intubation. However, it remains unclear whether videolaryngoscope will increase the successful tracheal intubation compared with usual Macintosch laryngoscope. Therefore, this pilot study is a randomized controlled trial designed to compare the first-pass intubation success of the Airtraq laryngoscope versus the Macintosh direct laryngoscope in patients requiring general anesthesia for elective operation, with the aims to examine the feasibility of a large multicentre effectiveness trial by assessing recruitment targets, testing the data completeness, and local incidence of first-pass intubation success.

Study Overview

• Status: Unknown
• Conditions: Intubation
• Intervention / Treatment: Procedure: Tracheal Intubation

Detailed Description

In recent decades, numerous videolaryngoscopes have been introduced to facilitate tracheal intubation. However, it remains unclear whether videolaryngoscope will increase the successful tracheal intubation compared with usual Macintosch laryngoscope. In a quantitative review on the performance of several non-standard laryngoscopes (e.g. Bonfils, CTrach, Glidescope), no strong evidence has been identified to support these devices to supersede the Macintosh laryngoscope. Owing to the lacks of randomized trials at the time, Airtraq has not been reviewed in the analysis.

The Airtraq laryngoscope is one of the optical indirect laryngoscopes, which provides glottis display without any deviation in the normal position of the oral, pharyngeal or the tracheal axes. Unlike other videolaryngoscopes, the Airtraq larygoscope is a non-steering novel airway device which has a guide channel for tracheal tube alongside with the blade. Its use has been showed to improve the ease of intubation in difficult airway situations. Up to date, randomized controlled trials comparing the Airtraq and Macintosh direct laryngoscopes are either small scaled or focusing on specific populations. And instead of the first-attempt success rate, the primary endpoints adopted have focused on the glottic view, intubation time, and cervical spine movement. The Difficult Airway Society has highlighted the importance of a robust and high standard of evidence to assess the use of new devices in airway management. Knowing that failed tracheal intubation has remained a major contribution to anesthetic-related morbidity and mortality, clinical relevant endpoint is essential to guide the selection of airway devices for tracheal intubation. Considering reports on unsuccessful tracheal intubation under satisfactory video-laryngoscopic view, using laryngoscopic view as a surrogate measure for successful intubation can give false assurances of device efficacy. While improvement in first-pass laryngoscopic success confers less airway trauma and possibly the prevention in deterioration to a 'Cannot Intubate Cannot Ventilate' scenario, it then translates into much more success than the improvement with multiple attempts and shortened intubation time. Meta-analyses have demonstrated that the Airtraq significantly decreased intubation time both in novice and in experienced anaesthetists compared with the Macintosh laryngoscope. Whereas in the first-attempt intubation, an increase in the first-pass success rate was only found in novice anaesthetists with significant analysis heterogeneity.

In view of these, a large pragmatic effectiveness trial using first-pass intubation success as the primary endpoint to compare the Airtraq and Macinotosh direct laryngoscope is necessary. The trial population should include normal and abnormal airways, a variety of elective and non-elective patients and proceduralists with mixed experience to allow results to be generalizable. A large trial would allow testing of subgroup effects that has not been previously possible and results would be generalizable due to its pragmatic design. The results of this trial will provide improved guidance for current airway algorithms.

• Study Type: Interventional
• Enrollment (Anticipated): 1586
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Anaesthesia and Intensive Care, New Territories West Cluster, Hospital Authority
    • Contact: Matthew TV Chan, MBBS; Phone Number: +852 91363821; Email: mtvchan@cuhk.edu.hk
    • Contact: Carmen KM Lam, MBBS; Phone Number: +852 90804633; Email: carmenlam1013@gmail.com
    • Sub-Investigator: Carmen KM Lam, MBBS
    • Sub-Investigator: Benny CP Cheng, MBBS
    • Principal Investigator: Angela SY Lam, MBChB
    • Sub-Investigator: Chung-wai Lau, MBBS

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. adult (>18years) patients;
2. receiving general anaesthesia that requires tracheal intubation

Exclusion Criteria:

1. known or predicted difficult bag-mask ventilation
2. patients scheduled for (awake or asleep) fibreoptic intubation
3. patients requiring rapid sequence intubation
4. language or congnitive problems that preclude adequate informed consent being obtained
5. patient or anaesthetist refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Airtraq; Airtraq laryngoscope	Procedure: Tracheal Intubation; Tracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope
Active Comparator: Macintosh; Macintosh laryngoscope	Procedure: Tracheal Intubation; Tracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-pass success in tracheal intubation	Successful tracheal intubation during the first attempt, confirmed by EtCO2 tracing	During tracheal intubation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to successful tracheal intubation	Duration when laryngoscope was inserted into mouth and successful tracheal intubation with the first appearance of EtCO2 tracing	During tracheal intubation procedure
Hoarseness	Subjective report of hoarseness in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe)	At 48 hours after operation
Sore throat	Subjective report of sore throat in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe)	At 48 hours after operation
Use of adjuncts during tracheal intubation	Adjuncts e.g. bougie, stylet used for tracheal intubation	During tracheal intubation procedure
Requirement of additional maneuvers	Use of additional maneuvers applied to facilitate tracheal intubation e.g. BUPA, patient re-positioning during tracheal intubation	During tracheal intubation procedure

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Tuen Mun Hospital
• Investigators: Principal Investigator: Mathew TV Chan, MBBS, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Mihai R, Blair E, Kay H, Cook TM. A quantitative review and meta-analysis of performance of non-standard laryngoscopes and rigid fibreoptic intubation aids. Anaesthesia. 2008 Jul;63(7):745-60. doi: 10.1111/j.1365-2044.2008.05489.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: First-pass; first attempt;intubation success
• Other Study ID Numbers: FAIR AiM protocol V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No