Airtraq Versus Conventional Laryngoscopy in Children

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

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 Overview

• Status: Completed
• Conditions: Children; Intubation; General Anesthesia
• Intervention / Treatment: Device: Airtraq laryngoscopy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS2 8BJ
    • Bristol Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional; conventional laryngoscopy for intubation
Experimental: Airtraq; laryngoscopy with Airtraq for intubation	Device: Airtraq laryngoscopy; laryngoscopy and intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time taken to successful intubation	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).	30 mins

Secondary Outcome Measures

Outcome Measure	Time Frame
Grade of laryngoscopy	30 mins
POGO score	30 mins
VAS ease of intubation	30 mins
evidence of traumatic intubation	24 hours

Collaborators and Investigators

• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
• Collaborators: Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: September 29, 2010
• First Posted (Estimate): September 30, 2010

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: children; intubation; laryngoscope
• Other Study ID Numbers: CH/2009/3387