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

NCT ID: NCT00992628

Last Updated: 2011-04-15

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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Patients undergoing surgery or intensive care management often require a tube to be inserted into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow visualisation of the larynx and facilitate intubation.

During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's mouth and the structures pulled upwards out of the line of vision. If visualisation is difficult, users often exert excess force on the tissues to obtain an adequate view. Generally the applied force is evaluated by the patient's stress response such as increased heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be confounded by a variety of patient factors, as well as anaesthesia. An increased force may also be associated with tissue trauma, dental damage, and prolonged attempts.

The investigators' objective is to compare the force exerted on patient's tissues by the Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be associated with the application of reduced force to the soft tissues of patients during intubation. While this is a common contention, it has not been proven. The GlideScope has a micro camera in the distal portion of the blade meaning a direct line of vision is not required. An adequate view can therefore be obtained with less displacement of tongue tissue. If the force exerted by the video laryngoscope is less, this would have beneficial implications by reducing stress response, neck movement, and trauma.

Detailed Description

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Conditions

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Endotracheal Intubation Laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Macintosh (direct vision) laryngoscope

Macintosh (direct vision) laryngoscope

Group Type ACTIVE_COMPARATOR

Macintosh (direct vision) laryngoscope

Intervention Type DEVICE

Macintosh (direct vision) laryngoscope

GlideScope videolaryngoscope (indirect vision)

GlideScope videolaryngoscope (indirect vision)

Group Type ACTIVE_COMPARATOR

GlideScope videolaryngoscope (indirect vision)

Intervention Type DEVICE

GlideScope videolaryngoscope (indirect vision)

Interventions

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Macintosh (direct vision) laryngoscope

Macintosh (direct vision) laryngoscope

Intervention Type DEVICE

GlideScope videolaryngoscope (indirect vision)

GlideScope videolaryngoscope (indirect vision)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age \> 18years
* ASA 1-2
* elective surgery
* endotracheal intubation required (with non-depolarising muscle relaxant)
* signed informed consent

Exclusion Criteria

* lack of informed consent
* endotracheal intubation not required
* ASA 3-5
* symptomatic gastro-oesophageal reflux
* rapid sequence intubation
* other method of intubation indicated eg fibreoptic, awake tracheostomy
* cervical spine instability
* unstable hypertension
* coronary artery disease
* cerebral disease
* COPD/asthma
* oral/pharyngeal/laryngeal carcinoma
* loose teeth/poor dentition
* Macintosh laryngoscope \>size 3 required
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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Toronto General Hospital, University Health Network

Principal Investigators

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Richard Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Toronto General Hospital, UHN

Toronto, Ontario, Canada

Site Status

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 09-0262-B

Identifier Type: -

Identifier Source: org_study_id

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