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

January 17, 2013 updated by: Mogens Ydemann Nielsen, Glostrup University Hospital, Copenhagen

Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Zeeland
      • Glostrup, Zeeland, Denmark, 2600
        • Department of Anesthesiology, Copenhagen University Hospital
      • Soeborg, Zeeland, Denmark, 2860
        • Privathospitalet Hamlet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >/= 35

Exclusion Criteria:

  • need for crash induction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fastrach
50 persons beeing intubated using the Fastrach.
Device: Fastrach
The Fastrach is an intubation laryngeal mask.
EXPERIMENTAL: GlideScope
50 persons beeing intubated using the GlideScope.
Device: GlideScope
The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Intubated in the First Attempt
Time Frame: please see description
The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).
please see description
Time to Intubate
Time Frame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.

Secondary Outcome Measures

Outcome Measure
Time Frame
Lowest Saturation During Intubation.
Time Frame: measured on the monitor
measured on the monitor
Mucosal Lesion
Time Frame: inspection during intubation and one hour postop.
inspection during intubation and one hour postop.
Subjectively Intubation Difficulty
Time Frame: measured immediately on a visual analogue scale.
measured immediately on a visual analogue scale.
Intubation of the Esophagus.
Time Frame: detected immediately
detected immediately
Postoperative Hoarseness.
Time Frame: one hour postoperative.
one hour postoperative.
Postoperative Throat Pain.
Time Frame: one hour postoperative
one hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Mogens VY Nielsen, MD, Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2010-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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