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A Comparison of Two GlideScope Intubation Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865643
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intubation, Endotracheal Anesthesia, General Device: GlideScope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparison of Two GlideScope Intubation Techniques - Effect on Hemodynamic Changes and Injury Rate
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
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.
Device: GlideScope
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.
Device: GlideScope
The GlideScope is used to assist with difficult tracheal intubation.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: 10 minutes ]
    Time for intubation will be measured as time from laryngoscopy to the inflation of the ETT cuff.

  2. Success rate [ Time Frame: 10 minutes ]
    Successful placement of endotracheal tube between the vocal cords.

  3. Injury rate [ Time Frame: 30 minutes ]
    Injuries to the oropharynx



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01865643


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Zeev Friedman, MD MOUNT SINAI HOSPITAL

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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01865643    
Other Study ID Numbers: 13-03
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Laryngoscopy
Intubation
Glidescope