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IntubationFAIRAiMNCT03887897

First Attempt Intubation Rate With Airtraq vs Macintosh Direct Laryngoscope

A study testing Tracheal Intubation in people with Intubation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation
What is being tested?
Tracheal Intubation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,586 participants
Where
1 siteHong Kong
Study dates
2 Oct 2019to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult (>18years) patients;
  • receiving general anaesthesia that requires tracheal intubation

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Matthew TV Chan, MBBS contact

+852 91363821

mtvchan@cuhk.edu.hk

Carmen KM Lam, MBBS contact

+852 90804633

carmenlam1013@gmail.com

Hong Kong1 site, 1 recruiting
  • Department of Anaesthesia and Intensive Care, New Territories West Cluster, Hospital Authority

    Hong Kong

    Matthew TV Chan, MBBS, +852 91363821, mtvchan@cuhk.edu.hk

    Carmen KM Lam, MBBS, +852 90804633, carmenlam1013@gmail.com

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Conditions
Intubation
Being tested
Tracheal Intubation
Keywords
First-pass; first attempt;intubation success

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tracheal IntubationProcedure or surgery

    Tracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope

Study groups in NCT03887897
Study groupRoleWhat they receive
AirtraqActive comparatorAirtraq laryngoscope
Receives: Procedure: Tracheal Intubation
MacintoshActive comparatorMacintosh laryngoscope
Receives: Procedure: Tracheal Intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First-pass success in tracheal intubation

    Successful tracheal intubation during the first attempt, confirmed by EtCO2 tracing

    Measured: During tracheal intubation procedure

Secondary outcomes (5)
  1. Time to successful tracheal intubation

    Duration when laryngoscope was inserted into mouth and successful tracheal intubation with the first appearance of EtCO2 tracing

    Measured: During tracheal intubation procedure

  2. Hoarseness

    Subjective report of hoarseness in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe)

    Measured: At 48 hours after operation

  3. Sore throat

    Subjective report of sore throat in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe)

    Measured: At 48 hours after operation

  4. Use of adjuncts during tracheal intubation

    Adjuncts e.g. bougie, stylet used for tracheal intubation

    Measured: During tracheal intubation procedure

  5. Requirement of additional maneuvers

    Use of additional maneuvers applied to facilitate tracheal intubation e.g. BUPA, patient re-positioning during tracheal intubation

    Measured: During tracheal intubation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start2 Oct 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,586 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887897
Sponsor's protocol ID
FAIR AiM protocol V1.0
Acronym
FAIRAiM
Status last verified
Nov 2019
First submitted
20 Mar 2019
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18582261

Questions about this trial

What is this clinical trial studying?

A study testing Tracheal Intubation in people with Intubation, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthew TV Chan, MBBS (+852 91363821, mtvchan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First-pass success in tracheal intubation (time frame: During tracheal intubation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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