Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

Obesity Clinical Trial

Official title:

Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917033
• Other study ID #: LHA GS 01
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: February 23, 2010
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, General
• Intubation, Endotracheal
• Obesity

Intervention

Device:
• GlideScope
Orotracheal intubation
• Macintosh direct laryngoscope
Orotracheal intubation

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Glostrup University Hospital	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubate		Measured during intubation (seconds)	Yes
Secondary	Number of intubation attempts		Measured during intubation (seconds)	No
Secondary	Lowest arterial oxygen saturation during intubation		Measured during intubation (seconds)	Yes
Secondary	Subjective difficulty of intubation		Measured during intubation (seconds)	No
Secondary	Cormack-Lehane Score		Measured during intubation (seconds)	No
Secondary	Airway mucosal trauma		Measured during intubation (seconds)	Yes
Secondary	Dental injury		Measured during intubation (seconds)	Yes
Secondary	Post-procedure sore throat		One hour post-operative	Yes
Secondary	Post-procedure hoarseness of voice		One hour post-operative	Yes