Airtraq Versus Conventional Laryngoscopy in Children

NCT01212536 | Completed

• 1 other identifier: CH/2009/3387
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Children; General Anesthesia; Intubation

Keywords

children; intubation; laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Grade of laryngoscopy

  30 mins

• POGO score

  30 mins

• VAS ease of intubation

  30 mins

• evidence of traumatic intubation

  24 hours

Study Arms (2)

Conventional

NO INTERVENTION

conventional laryngoscopy for intubation

Airtraq

EXPERIMENTAL

laryngoscopy with Airtraq for intubation

Device: Airtraq laryngoscopy

Interventions

Airtraq laryngoscopy DEVICE

laryngoscopy and intubation

Airtraq

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• inability of patient or parents to understand the study or consent process
• known or suspected difficult airway
• ASA 4 and above

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Bristol Childrens hospital

Bristol, Bristol, BS2 8BJ, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Paediatric Anaesthesia and Critical Care

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: September 30, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

GB (1)