Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM

NCT ID: NCT01237080

Last Updated: 2013-02-20

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.

The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.

Detailed Description

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The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.

Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.

Conditions

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Morbidly Obese Intubationtime Intubationattempts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fastrach

50 persons beeing intubated using the Fastrach.

Group Type EXPERIMENTAL

Fastrach

Intervention Type DEVICE

The Fastrach is an intubation laryngeal mask.

GlideScope

50 persons beeing intubated using the GlideScope.

Group Type EXPERIMENTAL

GlideScope

Intervention Type DEVICE

The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.

Interventions

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GlideScope

The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.

Intervention Type DEVICE

Fastrach

The Fastrach is an intubation laryngeal mask.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BMI \>/= 35

Exclusion Criteria

* need for crash induction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mogens Ydemann Nielsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mogens VY Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark

Locations

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Department of Anesthesiology, Copenhagen University Hospital

Glostrup Municipality, Zeeland, Denmark

Site Status

Privathospitalet Hamlet

Soeborg, Zeeland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2010-058

Identifier Type: -

Identifier Source: org_study_id

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