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

Not Applicable

Completed

• Conditions: Morbidly Obese; Intubationtime; Intubationattempts

• Registration Number: NCT01237080
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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®.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-10-29
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Results First Posted: 2013-02-20
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI >/= 35

Exclusion Criteria

• need for crash induction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients Intubated in the First Attempt	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).
Time to Intubate	From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.

Secondary Outcome Measures

Name	Time	Method
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.
Postoperative Throat Pain.	one hour postoperative

Trial Locations

Locations (2)

Department of Anesthesiology, Copenhagen University Hospital; 🇩🇰 Glostrup, Zeeland, Denmark

Privathospitalet Hamlet; 🇩🇰 Soeborg, Zeeland, Denmark