Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation

June 20, 2014 updated by: Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital

Exclusion Criteria:

  • moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
  • inability to communicate in English or French
  • contraindications to the drugs used in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Videolaryngoscope
Intubation by videolaryngoscope
Device: Videolaryngoscope
Other Names:
  • Intubation by Glidoscope
Active Comparator: Fiberoptic
Intubation by fibroscope
Device: Fiberoptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time required for successful intubation
Time Frame: 10 minutes
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.
Time Frame: 10 minutes
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ease of intubation using a 10 cm visual analogue scale, completed both by the person performing the intubation, and an independent observer.
Time Frame: one hour
one hour
Post-operatively the patient's satisfaction
Time Frame: 24 hours
Post-operatively the patient's satisfaction with the procedure using a 10 cm visual analogue scale, a discomfort scale using a 10 cm visual analogue scale, whether they would recommend this procedure to a future patient, and the severity of sore throat using a 10 cm visual analogue scale.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Albert Moore, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-443-SDR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Need of Awake Intubation for Difficult Airways

Clinical Trials on Videolaryngoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe