Airtraq Versus Conventional Laryngoscopy in Children

This study has been completed.
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01212536
First received: July 15, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Children
General Anesthesia
Intubation
Device: Airtraq laryngoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children

Resource links provided by NLM:


Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • time taken to successful intubation [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Grade of laryngoscopy [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • POGO score [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • VAS ease of intubation [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • evidence of traumatic intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional
conventional laryngoscopy for intubation
Experimental: Airtraq
laryngoscopy with Airtraq for intubation
Device: Airtraq laryngoscopy
laryngoscopy and intubation

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212536

Locations
United Kingdom
Bristol Childrens hospital
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
Oxford University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT01212536     History of Changes
Other Study ID Numbers: CH/2009/3387
Study First Received: July 15, 2010
Last Updated: December 14, 2011
Health Authority: United Kingdom: NRES

Keywords provided by University Hospitals Bristol NHS Trust:
children
intubation
laryngoscope

ClinicalTrials.gov processed this record on September 22, 2014