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GlideScope Video Laryngoscope Versus Fiberoptic Intubation

NCT ID: NCT01091948

Last Updated: 2016-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

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Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

Detailed Description

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Conditions

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Oral Intubation

Keywords

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elective general surgery orotracheal intubation Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Fiberoptic Intubation

Subjects will be intubated with the Fiberoptic laryngoscope.

Group Type ACTIVE_COMPARATOR

Intubation with Fiberoptic laryngoscope

Intervention Type DEVICE

Subjects will be intubated with the Fiberoptic laryngoscope.

GlideScope® Video Laryngoscope

Subjects will be intubated with the GlideScope® Video Laryngoscope.

Group Type ACTIVE_COMPARATOR

GlideScope® Video Laryngoscope

Intervention Type DEVICE

Patients will be intubated with the GlideScope® Video Laryngoscope.

Interventions

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Intubation with Fiberoptic laryngoscope

Subjects will be intubated with the Fiberoptic laryngoscope.

Intervention Type DEVICE

GlideScope® Video Laryngoscope

Patients will be intubated with the GlideScope® Video Laryngoscope.

Intervention Type DEVICE

Other Intervention Names

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Fiberoptic laryngoscope GlideScope® Video Laryngoscope

Eligibility Criteria

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Inclusion Criteria

* at least 18 years old
* scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria

* known, difficult airway
* loose teeth
* pregnant
* require a rapid sequence induction,
* Body Mass Index under 30
* unable to give consent
* if special endotracheal tube (ETT) is needed for the case.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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08-079

Identifier Type: -

Identifier Source: org_study_id