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Airtraq Versus Conventional Laryngoscopy in Children

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ClinicalTrials.gov Identifier: NCT01212536
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : December 15, 2011
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Children General Anesthesia Intubation Device: Airtraq laryngoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Conventional
conventional laryngoscopy for intubation
Experimental: Airtraq
laryngoscopy with Airtraq for intubation
 Device: Airtraq laryngoscopy
laryngoscopy and intubation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212536


Locations
United Kingdom
Bristol Childrens hospital
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
Oxford University Hospitals NHS Trust
More Information
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Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01212536     History of Changes
Other Study ID Numbers: CH/2009/3387
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

Keywords provided by Michelle White, University Hospitals Bristol NHS Foundation Trust:
children
intubation
laryngoscope