- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865643
A Comparison of Two GlideScope Intubation Techniques
A Comparison of Two GlideScope Intubation Techniques - Effect on Hemodynamic Changes and Injury Rate
The aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate.
The investigators hypothesize that the alternative intubation technique will have a shorter procedure time and lower injury rate when compared to the standard technique of GS intubation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A Difficult intubation is still one of the most daunting challenges in anesthesiology. One of the tools used to assist with a difficult tracheal intubation is the GlideScope (GS) (Verathon, Bothell, WA, USA). The GS is a video laryngoscope that has a 60 degree angle blade with a built-in high-resolution camera and a light source assembled beside it. The image is transmitted onto a mobile bedside monitor. It has been widely used in medicine for over a decade. The GS was designed to provide an improved view of the glottis during difficult intubations without alignment of the oral, pharyngeal and tracheal axes, as it is able to "look around the corner" to facilitate the intubation.
The standard technique of the GS intubation involves a midline laryngoscopy followed by the insertion of a styleted endotracheal tube (ETT) once an adequate view of the vocal cords has been achieved. The ETT insertion process requires the operator to look away from the monitor during the laryngoscopy while maintaining the blade position in order to insert it into its initial position.
An alternative GS intubation technique has been described for cases in which there is limited mouth opening, a big tongue or other anatomical impediments. In these cases the ETT is inserted under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.
There are several advantages to this alternative technique. The first advantage is that this technique of ETT insertion would minimize the laryngoscopy time as a part of it is performed before the blade is introduced and the stimulating effect occurs. This technique thus has the potential of reducing the sympathetic response. Minimizing oropharyngo-laryngeal stimulation time would theoretically attenuate the hemodynamic response.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of ASA physical status 1-2
- Patients aged 18 years and older
- Patients undergoing elective surgery that requires tracheal intubation
Exclusion Criteria:
- Patients in whom a rapid sequence intubation or alternative intubation method is indicated
- Patients with a known or suspected oral, pharyngeal or laryngeal mass
- Patients previously flagged as a difficult intubation
- Patients with hypertension (treated or untreated, poor dentition, symptomatic gastro-esophageal reflux or cervical spine instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard GlideScope intubation
This standard GlideScope (GS) technique involves a midline larygoscopy followed by insertion of a styleted endotracheal tube, once an adequate view of the vocal cords is achieved.
|
The GlideScope is used to assist with difficult tracheal intubation.
|
|
Experimental: Alternative GlideScope intubation
Alternative GlideScope (GS) intubation involves the insertion of the endotracheal tube under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.
|
The GlideScope is used to assist with difficult tracheal intubation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic response to tracheal intubation
Time Frame: 24 hours
|
Heart rate and non-invasive blood pressure will be measured before induction, and throughout and after laryngoscopy and induction
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure time
Time Frame: 10 minutes
|
Time for intubation will be measured as time from laryngoscopy to the inflation of the ETT cuff.
|
10 minutes
|
|
Success rate
Time Frame: 10 minutes
|
Successful placement of endotracheal tube between the vocal cords.
|
10 minutes
|
|
Injury rate
Time Frame: 30 minutes
|
Injuries to the oropharynx
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zeev Friedman, MD, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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