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Clinical Trials/NCT01212536
NCT01212536
Completed
Not Applicable

Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children

University Hospitals Bristol and Weston NHS Foundation Trust1 site in 1 country60 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Enrollment
60
Locations
1
Primary Endpoint
time taken to successful intubation
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle White

Consultant in Paediatric Anaesthesia and Critical Care

University Hospitals Bristol and Weston NHS Foundation Trust

Eligibility Criteria

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

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)

Study Sites (1)

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