Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- time taken to successful intubation
Study Overview
Brief Summary
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- — to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
- •Classified by the American Society of Anesthesiology (ASA) as grade 1-
- •Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.
Exclusion Criteria
- •inability of patient or parents to understand the study or consent process
- •known or suspected difficult airway
- •ASA 4 and above
Arms & Interventions
Conventional
conventional laryngoscopy for intubation
Airtraq
laryngoscopy with Airtraq for intubation
Intervention: Airtraq laryngoscopy (Device)
Outcomes
Primary Outcomes
time taken to successful intubation
Time Frame: 30 mins
The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace).
Secondary Outcomes
- Grade of laryngoscopy(30 mins)
- POGO score(30 mins)
- VAS ease of intubation(30 mins)
- evidence of traumatic intubation(24 hours)
Investigators
Michelle White
Consultant in Paediatric Anaesthesia and Critical Care
University Hospitals Bristol and Weston NHS Foundation Trust