Skip to main content
OpenTrials
Completed

NCT Number: NCT01212536

Airtraq Versus 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children General Anesthesia Intubation

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Childrens hospital

Bristol, BS2 8BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airtraq laryngoscopy

Device

laryngoscopy and intubation

Primary outcomes

  1. 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

  1. Grade of laryngoscopy

    Time frame: 30 mins

  2. POGO score

    Time frame: 30 mins

  3. VAS ease of intubation

    Time frame: 30 mins

  4. evidence of traumatic intubation

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.