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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01564082
Other study ID # 18855
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated April 9, 2015
Start date April 2012
Est. completion date March 2013

Study information

Verified date April 2015
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada London Health Sciences Center London Ontario
Canada St. Joseph's Health Care London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Intubation Duration of intubation of the patient Day 1 No
Secondary Ease of intubation Ease of intubation, measured on a Visual analog scale Day 1 No
Secondary Number of intubation attempts Number of intubation attempts Day 1 No
Secondary Use of external laryngeal pressure Use of external laryngeal pressure Day 1 No
Secondary Sore throat Post operative sore throat, as rated by the patient. Day 3 No
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