Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

February 23, 2010 updated by: Glostrup University Hospital, Copenhagen

Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.

The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, DK-2600
        • Department of Anesthesia, Glostrup University Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
  • Body Mass Index at least 35 kg/m2
  • Written informed consent to participate

Exclusion Criteria:

  • Mental illness
  • Abuse of alcohol or other substances
  • Previous difficult tracheal intubation
  • Considered non-eligible for safety-reasons by the anesthetist in charge

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GlideScope
Orotracheal intubation using the GlideScope videolaryngoscope
Device: GlideScope
Orotracheal intubation
Active Comparator: Macintosh
Orotracheal intubation using the Macintosh direct laryngoscope
Device: Macintosh direct laryngoscope
Orotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to intubate
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of intubation attempts
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Lowest arterial oxygen saturation during intubation
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Subjective difficulty of intubation
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Cormack-Lehane Score
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Airway mucosal trauma
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Dental injury
Time Frame: Measured during intubation (seconds)
Measured during intubation (seconds)
Post-procedure sore throat
Time Frame: One hour post-operative
One hour post-operative
Post-procedure hoarseness of voice
Time Frame: One hour post-operative
One hour post-operative

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Lasse H Andersen, MD, Glostrup University Hospital

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

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • LHA GS 01

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.

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