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
  Purpose

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.


Condition Intervention
Oral Intubation
Device: Intubation with Fiberoptic laryngoscope
Device: GlideScope® Video Laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: GlideScope Video Laryngoscope vs Fiberoptic Intubation

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • time to intubation (TTI) as measured in seconds [ Time Frame: seconds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fiberoptic Intubation
Subjects will be intubated with the Fiberoptic laryngoscope.
Device: Intubation with Fiberoptic laryngoscope
Subjects will be intubated with the Fiberoptic laryngoscope.
Other Names:
  • Fiberoptic
  • laryngoscope
Active Comparator: GlideScope® Video Laryngoscope
Subjects will be intubated with the GlideScope® Video Laryngoscope.
Device: GlideScope® Video Laryngoscope
Patients will be intubated with the GlideScope® Video Laryngoscope.
Other Names:
  • GlideScope®
  • Video Laryngoscope

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01091948

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: John Doyle, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01091948     History of Changes
Other Study ID Numbers: 08-079
Study First Received: March 9, 2010
Last Updated: April 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
elective general surgery
orotracheal intubation
Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.

ClinicalTrials.gov processed this record on August 26, 2014