Intubation Clinical Trial
— FAIRAiMOfficial 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.
Status | Recruiting |
Enrollment | 1586 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Anaesthesia and Intensive Care, New Territories West Cluster, Hospital Authority | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Tuen Mun Hospital |
Hong Kong,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First-pass success in tracheal intubation | Successful tracheal intubation during the first attempt, confirmed by EtCO2 tracing | During tracheal intubation procedure | |
Secondary | 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 | |
Secondary | Hoarseness | Subjective report of hoarseness in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe) | At 48 hours after operation | |
Secondary | Sore throat | Subjective report of sore throat in terms of serverity (0=nil; 1=mild; 2=moderate; 3= severe) | At 48 hours after operation | |
Secondary | Use of adjuncts during tracheal intubation | Adjuncts e.g. bougie, stylet used for tracheal intubation | During tracheal intubation procedure | |
Secondary | 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 |
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