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Comparison of Early Endotracheal Tube Insertion With GlideScope Use

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ClinicalTrials.gov Identifier: NCT01564082
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients presenting for elective surgery will be randomized to having the breathing tube inserted partly into the throat prior to GlideScope insertion, or having it inserted fully after GlideScope insertion.

Condition or disease Intervention/treatment
Endotracheal Intubation Device: ETT First (GlideScope)

Detailed Description:
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the Early Endotracheal Tube (ETT) inserted into the pharynx prior to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the standard fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea. The primary outcome is time to intubation.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Early Endotracheal Tube Insertion With GlideScope Use
Study Start Date : April 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: ETT first
Patients will have the endotracheal tube (ETT) introduced into the pharynx prior to GlideScope insertion, and then advanced under GlideScope guidance into the trachea.
Device: ETT First (GlideScope)
Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea.
No Intervention: Control Group
Patients will have the GlideScope introduced into the pharynx. The endotracheal tube (ETT) will then be advanced under direct vision into the mouth/pharynx. The ETT will then be advanced into the trachea under GlideScope guidance.


Outcome Measures

Primary Outcome Measures :
  1. Time to Intubation [ Time Frame: Day 1 ]
    Duration of intubation of the patient


Secondary Outcome Measures :
  1. Ease of intubation [ Time Frame: Day 1 ]
    Ease of intubation, measured on a Visual analog scale

  2. Number of intubation attempts [ Time Frame: Day 1 ]
    Number of intubation attempts

  3. Use of external laryngeal pressure [ Time Frame: Day 1 ]
    Use of external laryngeal pressure

  4. Sore throat [ Time Frame: Day 3 ]
    Post operative sore throat, as rated by the patient.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Any adult patient booked for elective surgery requiring orotracheal intubation.
  2. Any operator who has performed ≥ 20 GlideScope intubations.

Exclusion Criteria:

  1. Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  2. Any patient with cervical spine abnormalities.
  3. Any patients with known or probable difficult airways.
  4. Any patient requiring rapid sequence induction.
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): NCT01564082


Locations
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
London Health Sciences Center
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Timothy P Turkstra, MD, M. Eng. LHRI
More Information

Responsible Party: Timothy Turkstra, Associate Professor and Staff Anesthesiologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01564082     History of Changes
Other Study ID Numbers: 18855
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Timothy Turkstra, Lawson Health Research Institute:
endotracheal intubation
GlideScope