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GlideScope Video Laryngoscope Versus Fiberoptic Intubation

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01091948
First received: March 9, 2010
Last updated: April 2, 2010
Last verified: March 2010
History of Changes

March 9, 2010
April 2, 2010
February 2008
June 2009   (final data collection date for primary outcome measure)
time to intubation (TTI) as measured in seconds [ Time Frame: seconds ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01091948 on ClinicalTrials.gov Archive Site
Ease of intubation [ Time Frame: seconds ] [ Designated as safety issue: No ]
Secondary outcomes will include ease of intubation (as recorded by the operator immediately after intubation on a 100 mm visual analog scale [VAS]),the glottic view, whether or not optimization maneuvers were used or not, the number of failures, the number of attempts made, and the amount of bleeding that occurred.
Same as current
Not Provided
Not Provided
 
GlideScope Video Laryngoscope Versus Fiberoptic Intubation
GlideScope Video Laryngoscope vs Fiberoptic Intubation

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Oral Intubation
  • Device: Intubation with Fiberoptic laryngoscope
    Subjects will be intubated with the Fiberoptic laryngoscope.
    Other Names:
    • Fiberoptic
    • laryngoscope
  • Device: GlideScope® Video Laryngoscope
    Patients will be intubated with the GlideScope® Video Laryngoscope.
    Other Names:
    • GlideScope®
    • Video Laryngoscope
  • Active Comparator: Fiberoptic Intubation
    Subjects will be intubated with the Fiberoptic laryngoscope.
    Intervention: Device: Intubation with Fiberoptic laryngoscope
  • Active Comparator: GlideScope® Video Laryngoscope
    Subjects will be intubated with the GlideScope® Video Laryngoscope.
    Intervention: Device: GlideScope® Video Laryngoscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2010
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

  • known, difficult airway
  • loose teeth
  • pregnant
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01091948
08-079
No
John Doyle, MD, Cleveland Clinic
Outcomes Research Consortium
Not Provided
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Outcomes Research Consortium
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP