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

NCT ID: NCT01814176

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Moderately Difficult to Intubate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope

Intervention Type DEVICE

GlideScope Video Laryngoscope

The GlideScope has a 60ยบ angulation anteriorly at the distal portion of the blade, allowing an anterior view of the larynx.

Group Type ACTIVE_COMPARATOR

Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope

Intervention Type DEVICE

Interventions

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Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Cordovani D, Russell T, Wee W, Suen A, Cooper RM. Measurement of forces applied using a Macintosh direct laryngoscope compared with a Glidescope video laryngoscope in patients with predictors of difficult laryngoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):221-226. doi: 10.1097/EJA.0000000000000901.

Reference Type DERIVED
PMID: 30308524 (View on PubMed)

Other Identifiers

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11-0229-B

Identifier Type: -

Identifier Source: org_study_id