Intubation Clinical Trial
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.
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.
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