Airtraq Versus Conventional Laryngoscopy in Children

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212536
• Other study ID #: CH/2009/3387
• 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

• Children
• General Anesthesia
• Intubation

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