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Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00459797
First received: April 12, 2007
Last updated: April 20, 2009
Last verified: April 2009
  Purpose
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.

Condition Intervention
Healthy Device: Conventional (reusable) Glidescope Device: Single-use Glidescope videolaryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Time to intubation (seconds) [ Time Frame: Immediate ]

Secondary Outcome Measures:
  • Ease of intubation [ Time Frame: after intubation ]
  • Number of intubation attempts per group [ Time Frame: after intubation ]
  • Incidence of trauma in each group [ Time Frame: after intubation ]
  • Number of failures to intubate per group [ Time Frame: after intubation ]
  • Use of external laryngeal pressure per group [ Time Frame: after intubation ]
  • Laryngoscopic grade distribution in each group [ Time Frame: after intubation ]

Enrollment: 100
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Glidescope Device: Conventional (reusable) Glidescope
Experimental: Single-use Glidescope Device: Single-use Glidescope videolaryngoscope

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient who is ≥ 18 yrs. coming for elective surgery.
  • Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
  • Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

  • Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  • Any patient with cervical spine abnormalities.
  • Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
  • Any patient requiring rapid sequence induction.
  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: NCT00459797

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Philip M Jones, MD London Health Sciences Centre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philip Jones, LHSC
ClinicalTrials.gov Identifier: NCT00459797     History of Changes
Other Study ID Numbers: R-07-040
13025
Study First Received: April 12, 2007
Last Updated: April 20, 2009

Keywords provided by Lawson Health Research Institute:
GlideScope
cobalt
single-use
intubation
airway
Elective surgical patients requiring orotracheal intubation

Additional relevant MeSH terms:
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017