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Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation

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ClinicalTrials.gov Identifier: NCT02169232
Recruitment Status : Unknown
Verified June 2014 by Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Need of Awake Intubation for Difficult Airways Device: Videolaryngoscope Device: Fiberoptic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Videolaryngoscope
Intubation by videolaryngoscope
Device: Videolaryngoscope
Other Name: Intubation by Glidoscope

Active Comparator: Fiberoptic
Intubation by fibroscope
Device: Fiberoptic



Primary Outcome Measures :
  1. 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.


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

Other Outcome Measures:
  1. 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 ]
  2. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02169232


Contacts
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Contact: Albert Moore, MD moore_albert@hotmail.com
Contact: Aly Elbahrawy, MD abahrawy@yahoo.com

Locations
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Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada
Contact: Albert Moore, MD       moore_albert@hotmail.com   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Albert Moore, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Albert Moore, Assistant professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02169232    
Other Study ID Numbers: 13-443-SDR
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Awake intubation
Videolaryngoscope
Fiberoptic