Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM
1 other identifier
interventional
100
1 country
2
Brief Summary
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
February 20, 2013
CompletedFebruary 20, 2013
January 1, 2013
4 months
November 8, 2010
October 29, 2012
January 17, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Patients Intubated in the First Attempt
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
From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
Secondary Outcomes (6)
Lowest Saturation During Intubation.
measured on the monitor
Mucosal Lesion
inspection during intubation and one hour postop.
Subjectively Intubation Difficulty
measured immediately on a visual analogue scale.
Intubation of the Esophagus.
detected immediately
Postoperative Hoarseness.
one hour postoperative.
- +1 more secondary outcomes
Study Arms (2)
Fastrach
EXPERIMENTAL50 persons beeing intubated using the Fastrach.
GlideScope
EXPERIMENTAL50 persons beeing intubated using the GlideScope.
Interventions
The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.
Eligibility Criteria
You may qualify if:
- BMI \>/= 35
You may not qualify if:
- need for crash induction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anesthesiology, Copenhagen University Hospital
Glostrup Municipality, Zeeland, 2600, Denmark
Privathospitalet Hamlet
Soeborg, Zeeland, 2860, Denmark
Limitations and Caveats
Acta Anaesthesiol Scand 2012; 56: 755-761
Results Point of Contact
- Title
- Mogens Ydemann
- Organization
- Department of Anaesthesiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Mogens VY Nielsen, MD
Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 9, 2010
Study Start
September 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 20, 2013
Results First Posted
February 20, 2013
Record last verified: 2013-01