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.
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.
Hong Kong1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Airtraq | Active comparator | Airtraq laryngoscope Receives: Procedure: Tracheal Intubation |
| Macintosh | Active comparator | Macintosh laryngoscope Receives: Procedure: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Hoarseness
Subjective report of hoarseness in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe)
Measured: At 48 hours after operation
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
Use of adjuncts during tracheal intubation
Adjuncts e.g. bougie, stylet used for tracheal intubation
Measured: 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
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.
- First posted25 Mar 2019
- Study start2 Oct 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tuen Mun Hospital
- Responsible party
- Principal investigator, Matthew Chan, Chinese University of Hong Kong
- Investigators
- Mathew TV Chan, MBBS, Principal investigator, Chinese University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03887897
- Acronym / sponsor ID
- FAIRAiM / FAIR AiM protocol V1.0
- Conditions
- Intubation
- Keywords
- First-pass; first attempt;intubation success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,586 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Tuen Mun Hospital
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq | Active comparator | Procedure: Tracheal IntubationAirtraq laryngoscope |
| Macintosh | Active comparator | Procedure: Tracheal IntubationMacintosh laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult (>18years) patients;
- receiving general anaesthesia that requires tracheal intubation
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheal IntubationTracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope | Procedure or surgery | Airtraq, Macintosh |
Primary outcome
First-pass success in tracheal intubation
Time frame: During tracheal intubation procedure
Successful tracheal intubation during the first attempt, confirmed by EtCO2 tracing
5 secondary outcomes
Time to successful tracheal intubation
Time frame: During tracheal intubation procedure
Hoarseness
Time frame: At 48 hours after operation
Sore throat
Time frame: At 48 hours after operation
Use of adjuncts during tracheal intubation
Time frame: During tracheal intubation procedure
Requirement of additional maneuvers
Time frame: During tracheal intubation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Background: PubMed 18582261Mihai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathew TV Chan, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
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.