Completed

NCT Number: NCT01814176

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

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.

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Key information

Conditions

Moderately Difficult to Intubate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M8X 1W4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope

Device

Primary outcomes

Peak forces during intubation

Time frame: Intraoperatively

Peak forces generated during the laryngoscopy and intubation process using both laryngoscopes.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope in Patients With at Least One Difficult Intubation Risk Factor

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 19, 2013
Registry last updated: Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.