Comparative Effectiveness of Intubating Devices in the Morbidly Obese

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

Brief Summary

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This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.

The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.

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Detailed Description

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Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Video-Mac

Video-Mac device used during intubation procedure

Group Type EXPERIMENTAL

Video-Mac

Intervention Type DEVICE

Intubation with the Video-Mac device

GlideScope

GlideScope device used during intubation procedure

Group Type EXPERIMENTAL

GlideScope

Intervention Type DEVICE

Intubation with the GlideScope device

McGrath

McGrath device used during intubation procedure

Group Type EXPERIMENTAL

McGrath

Intervention Type DEVICE

Intubation with the McGrath device

Direct Macintosh Laryngoscopy

Direct Macintosh Laryngoscopy (DL) used during intubation procedure

Group Type ACTIVE_COMPARATOR

Direct Macintosh Laryngoscopy

Intervention Type DEVICE

Intubation with Direct Macintosh Laryngoscope

Interventions

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McGrath

Intubation with the McGrath device

Intervention Type DEVICE

GlideScope

Intubation with the GlideScope device

Intervention Type DEVICE

Direct Macintosh Laryngoscopy

Intubation with Direct Macintosh Laryngoscope

Intervention Type DEVICE

Video-Mac

Intubation with the Video-Mac device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a documented body mass index (BMI) of \>35.
* Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
* Willingness and ability to sign an informed consent document
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

Exclusion Criteria

* Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
* Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
* Emergency surgeries
* Pregnancy
* The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.
* Any other conditions or use of any medication which may interfere with the conduct of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No