A Comparison of Two GlideScope Intubation Techniques

Anesthesia, General Clinical Trial

Official title:

A Comparison of Two GlideScope Intubation Techniques - Effect on Hemodynamic Changes and Injury Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865643
• Other study ID #: 13-03
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: August 19, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia, General
• Intubation, Endotracheal

Intervention

Device:
• GlideScope
The GlideScope is used to assist with difficult tracheal intubation.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic response to tracheal intubation	Heart rate and non-invasive blood pressure will be measured before induction, and throughout and after laryngoscopy and induction	24 hours	No
Secondary	Procedure time	Time for intubation will be measured as time from laryngoscopy to the inflation of the ETT cuff.	10 minutes	No
Secondary	Success rate	Successful placement of endotracheal tube between the vocal cords.	10 minutes	No
Secondary	Injury rate	Injuries to the oropharynx	30 minutes	No