Comparison of Early Endotracheal Tube Insertion With GlideScope Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01564082
First received: March 6, 2012
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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 Intervention
Endotracheal Intubation
Device: ETT First (GlideScope)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Early Endotracheal Tube Insertion With GlideScope Use

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Time to Intubation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Duration of intubation of the patient


Secondary Outcome Measures:
  • Ease of intubation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Ease of intubation, measured on a Visual analog scale

  • Number of intubation attempts [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of intubation attempts

  • Use of external laryngeal pressure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Use of external laryngeal pressure

  • Sore throat [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Post operative sore throat, as rated by the patient.


Estimated Enrollment: 160
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01564082

Contacts
Contact: Jamie Allaer 5196858500 ext 33022 jamie.allaer@lhsc.on.ca

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

No publications provided

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
Study First Received: March 6, 2012
Last Updated: January 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
endotracheal intubation
GlideScope

ClinicalTrials.gov processed this record on August 01, 2014