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Airtraq Versus Conventional Laryngoscopy in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01212536
Enrollment
60
Registered
2010-09-30
Start date
2010-08-31
Completion date
2011-03-31
Last updated
2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, General Anesthesia, Intubation

Keywords

children, intubation, laryngoscope

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.

Interventions

DEVICEAirtraq laryngoscopy

laryngoscopy and intubation

Sponsors

Oxford University Hospitals NHS Trust
CollaboratorOTHER
University Hospitals Bristol and Weston NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
time taken to successful intubation30 minsThe 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

MeasureTime frame
Grade of laryngoscopy30 mins
POGO score30 mins
VAS ease of intubation30 mins
evidence of traumatic intubation24 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026