Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

Phase 4

Completed

• Conditions: Intubation, Endotracheal; Anesthesia, General; Obesity
• Interventions: Device: GlideScope; Device: Macintosh direct laryngoscope

• Registration Number: NCT00917033
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

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

Inclusion Criteria

• Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
• Body Mass Index at least 35 kg/m2
• Written informed consent to participate

Exclusion Criteria

• Mental illness
• Abuse of alcohol or other substances
• Previous difficult tracheal intubation
• Considered non-eligible for safety-reasons by the anesthetist in charge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GlideScope	GlideScope	Orotracheal intubation using the GlideScope videolaryngoscope
Macintosh	Macintosh direct laryngoscope	Orotracheal intubation using the Macintosh direct laryngoscope

Primary Outcome Measures

Name	Time	Method
Time to intubate	Measured during intubation (seconds)

Secondary Outcome Measures

Name	Time	Method
Number of intubation attempts	Measured during intubation (seconds)
Lowest arterial oxygen saturation during intubation	Measured during intubation (seconds)
Subjective difficulty of intubation	Measured during intubation (seconds)
Cormack-Lehane Score	Measured during intubation (seconds)
Airway mucosal trauma	Measured during intubation (seconds)
Dental injury	Measured during intubation (seconds)
Post-procedure sore throat	One hour post-operative
Post-procedure hoarseness of voice	One hour post-operative

Trial Locations

Locations (1)

Department of Anesthesia, Glostrup University Hospital; 🇩🇰 Copenhagen, Glostrup, Denmark