Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope

Not Applicable

Completed

• Conditions: Moderately Difficult to Intubate
• Interventions: Device: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope

• Registration Number: NCT01814176
• Lead Sponsor: University Health Network, Toronto

Brief Summary

During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-03
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• age > 18years
• elective surgery
• single lumen endotracheal intubation required
• signed informed consent
• one risk factor for a difficult laryngoscopy ( Mallampati score >3, inter-incisor gap < 3.5cm, thyromental distance < 6.5cm, sternomental distance < 12.5cm, reduced neck extension and flexion)

Exclusion Criteria

• lack of patient consent
• anesthesiologist declines to consent
• contraindication to neuromuscular blockade
• ASA 4
• rapid sequence intubation
• previous failed intubation
• other method of intubation indicated eg fiberoptic intubation, awake tracheostomy
• symptomatic gastro-esophageal reflux
• cervical spine instability
• unstable hypertension and symptomatic coronary artery disease
• cerebrovascular disease or raised intracranial pressure
• oral/pharyngeal/laryngeal carcinoma
• loose teeth/poor dentition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GlideScope Video Laryngoscope	Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope	The GlideScope has a 60º angulation anteriorly at the distal portion of the blade, allowing an anterior view of the larynx.
Macintosh Direct Laryngoscope	Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope	2 main forces - a 'lifting' force to elevate the structures not in the line of sight and a force exerted by the user's wrist to counterbalance the torque effect of the tongue tissues on the blade

Primary Outcome Measures

Name	Time	Method
Peak forces during intubation	Intraoperatively	Peak forces generated during the laryngoscopy and intubation process using both laryngoscopes.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada