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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01212536
Other study ID # CH/2009/3387
Secondary ID
Status Completed
Phase N/A
First received July 15, 2010
Last updated December 14, 2011
Start date August 2010
Est. completion date March 2011

Study information

Verified date December 2011
Source University Hospitals Bristol NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: NRES
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Airtraq laryngoscopy
laryngoscopy and intubation

Locations

Country Name City State
United Kingdom Bristol Childrens hospital Bristol

Sponsors (2)

Lead Sponsor Collaborator
University Hospitals Bristol NHS Foundation Trust Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Grade of laryngoscopy 30 mins No
Secondary POGO score 30 mins No
Secondary VAS ease of intubation 30 mins No
Secondary evidence of traumatic intubation 24 hours No
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