Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00917033
First received: June 9, 2009
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to intubate [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of intubation attempts [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: No ]
  • Lowest arterial oxygen saturation during intubation [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: Yes ]
  • Subjective difficulty of intubation [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: No ]
  • Cormack-Lehane Score [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: No ]
  • Airway mucosal trauma [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: Yes ]
  • Dental injury [ Time Frame: Measured during intubation (seconds) ] [ Designated as safety issue: Yes ]
  • Post-procedure sore throat [ Time Frame: One hour post-operative ] [ Designated as safety issue: Yes ]
  • Post-procedure hoarseness of voice [ Time Frame: One hour post-operative ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917033

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

No publications provided

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
Study First Received: June 9, 2009
Last Updated: February 23, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on October 23, 2014