Airtraq Versus Conventional Laryngoscopy in Children

Not Applicable

Completed

• Conditions: Children; General Anesthesia; Intubation
• Interventions: Device: Airtraq laryngoscopy

• Registration Number: NCT01212536
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-15
• Study Start: 2010-08
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-14
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 1-3.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Airtraq	Airtraq laryngoscopy	laryngoscopy with Airtraq for intubation

Primary Outcome Measures

Name	Time	Method
time taken to successful intubation	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 Outcome Measures

Name	Time	Method
Grade of laryngoscopy	30 mins
POGO score	30 mins
VAS ease of intubation	30 mins
evidence of traumatic intubation	24 hours

Trial Locations

Locations (1)

Bristol Childrens hospital; 🇬🇧 Bristol, United Kingdom