Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation

NCT02169232 | Unknown DMC

• 1 other identifier: 13-443-SDR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Need of Awake Intubation for Difficult Airways

Keywords

Awake intubation; Videolaryngoscope; Fiberoptic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.

  10 minutes

Other Outcomes (2)

• 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

Study Arms (2)

Videolaryngoscope

ACTIVE COMPARATOR

Intubation by videolaryngoscope

Device: Videolaryngoscope

Fiberoptic

ACTIVE COMPARATOR

Intubation by fibroscope

Device: Fiberoptic

Interventions

Videolaryngoscope DEVICE

Also known as: Intubation by Glidoscope

Videolaryngoscope

Fiberoptic DEVICE

Fiberoptic

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Interventions

Optical Fibers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Officials

• Albert Moore, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Moore, MD

CONTACT

moore_albert@hotmail.com

Aly Elbahrawy, MD

CONTACT

abahrawy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

CA (1)