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A comparative study of the efficacy of the McGrath (Registered Trademark) X-blade vs the C-MAC Videolaryngoscope in patients with simulated difficult airways

A comparative study of the efficacy of the McGrath (Registered Trademark) X-blade vs the C-MAC Videolaryngoscope in patients with simulated difficult airways

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000668404
Acronym
None
Enrollment
210
Registered
2016-05-23
Start date
2016-06-16
Completion date
2019-04-29
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Videolaryngoscopes have been listed as part of the initial approach to intubation in international airway algorithms and guidelines, such as the 2013 ASA Practice Guidelines for Management of the Difficult Airway. Furthermore, meta-analyses of RCTs comparing video-assisted laryngoscopy with direct laryngoscopy in patients with simulated difficult airways report improved laryngeal views and a higher frequency of successful intubations. The McGrath X-blade, which is recently launched in June 2014, has been advocated to be useful in difficult airway situations. In addition, it is small and easily transportable for many clinical settings for tracheal intubation. Methodology - Our null hypothesis is that McGrath X-blade attachment is as efficacious as the C-MAC Videolaryngoscope in tracheal intubation of patients with simulated difficult airways. We aim to recruit 210 patients between 21 to 80 years old, ASA I to III to receive either CMAC or McGrath X-blade for intubation during elective operations. The primary outcome will be first-pass success (FPS). Secondary outcomes include overall intubation success, number of intubation attempts, total time to intubation (TTI), Cormack & Lehane grade, cardiorespiratory and intubation-related adverse events. Importance of proposed research to science or medicine If the McGrath X-blade video laryngoscope is shown to be better in efficacy to the C-MAC Videolaryngoscope in simulated difficult airway, it will be a useful portable airway adjunct in difficult airway situations, especially those occurring in remote locations e.g. radiology suites, general ward, ICUs, where access to difficult intubation equipment may be limited. Potential benefits & risks Risks to participants are no greater than what they would experience coming for a standard general anaesthetic and tracheal intubation. General risks related to tracheal intubation included sore throat, hoarseness of voice. Uncommon risks include dental injuries and rare but severe risks include hypoxia, increased blood pressure and heart rates.

Interventions

Use of the new X-blade attachment for the McGrath videolaryngoscope in patients undergoing general anaesthesia requiring tracheal intubation, with simulated difficult airway by manual in-line cervical stabilisation. The procedure will begin 3 minutes after the induction of general anaesthesia, before surgery could proceed. Once tracheal intubation is achieved, surgery will be allowed to commence at any time thereafter. The intervention is delivered by 3 anaesthesiology specialists and 2 senior a

Use of the new X-blade attachment for the McGrath videolaryngoscope in patients undergoing general anaesthesia requiring tracheal intubation, with simulated difficult airway by manual in-line cervical stabilisation. The procedure will begin 3 minutes after the induction of general anaesthesia, before surgery could proceed. Once tracheal intubation is achieved, surgery will be allowed to commence at any time thereafter. The intervention is delivered by 3 anaesthesiology specialists and 2 senior anaesthesiology residents, all of whom have 5/more years of experience in anaesthesiology. The study device (X-blade) is an angulated blade attachment for the McGrath cideolaryngoscope, with a curvature of 60 degrees. The control device (C-MAC videolarygoscope) has a lesser curvature of approx 30-40 degrees. Hence the view of the glottis obtained with the 2 blades are slightly different.

Sponsors

Zhang Jinbin
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 21 to 80 years old 2. American Society of Anaesthesiologists (ASA) Physical Status Class I to III 3. Elective operations requiring general anaesthesia and tracheal intubation

Exclusion criteria

1. Clinical evidence of difficult airway: a. Mallampathi Class 3 & 4 b. Thyromental distance <6cm c. Interincisor distance < 3.5cm d. Previous documented difficult laryngoscopy or bag mask ventilation 2. Pre-existing dental risks e.g. loose tooth 3. Morbidly obese patients with BMI > 35kg/m2 4. Pre-existing cervical spondylosis/ myelopathy 5. Aspiration risks (unfasted, GERD, hiatus hernia) 6. where awake tracheal intubation is indicated 7. Patients who refuse to participate or lack the capacity to give consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026