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Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 10, 2009
Last Update Posted: February 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Glostrup University Hospital, Copenhagen
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.

Condition Intervention Phase
Intubation, Endotracheal Anesthesia, General Obesity Device: GlideScope Device: Macintosh direct laryngoscope Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Time to intubate [ Time Frame: Measured during intubation (seconds) ]

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

Enrollment: 100
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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): NCT00917033

Department of Anesthesia, Glostrup University Hospital
Copenhagen, Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Lasse H Andersen, MD Glostrup University Hospital
  More Information

Responsible Party: Mr. Lasse Hoegh Andersen, M.D., Department of Anaesthesia, Glostrup University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00917033     History of Changes
Other Study ID Numbers: LHA GS 01
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: February 24, 2010
Last Verified: February 2010