NCT02169232|UnknownDMC
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Sponsor study identifier
interventional
40
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 19, 2014
Actual (reported)June 23, 2014
Actual (reported)May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The time required for successful intubation
The time required for successful intubation, which will be measured as the time from which the bronchoscope or videolaryngoscope is initially introduced into the oropharynx, until the time that CO2 is registered on the capnogram.
10 minutes
Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.
10 minutes
The ease of intubation using a 10 cm visual analogue scale, completed both by the person performing the intubation, and an independent observer.
one hour
Post-operatively the patient's satisfaction
24 hours
Intubation by videolaryngoscope
Intubation by fibroscope
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Victoria Hospital
Montreal, Quebec, Canada
Albert Moore, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
June 19, 2014
First Posted
June 23, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2014
Record last verified: 2014-06
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Source: ClinicalTrials.gov.
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