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

History of Changes

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

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


children intubation laryngoscope

ClinicalTrials.gov processed this record on March 03, 2015

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