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

Morbidly Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237080
• Other study ID #: H-1-2010-058
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: January 17, 2013
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: the regional scientific ethics committee of the regional capitalDenmark: data monitoring agency
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI >/= 35

Exclusion Criteria:

• need for crash induction.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubationattempts
• Intubationtime
• Morbidly Obese

Intervention

Device:
• GlideScope
The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.
• Fastrach
The Fastrach is an intubation laryngeal mask.

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Copenhagen University Hospital	Glostrup	Zeeland
Denmark	Privathospitalet Hamlet	Soeborg	Zeeland

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	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	No
Primary	Time to Intubate		From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.	No
Secondary	Lowest Saturation During Intubation.		measured on the monitor	No
Secondary	Mucosal Lesion		inspection during intubation and one hour postop.	No
Secondary	Subjectively Intubation Difficulty		measured immediately on a visual analogue scale.	No
Secondary	Intubation of the Esophagus.		detected immediately	No
Secondary	Postoperative Hoarseness.		one hour postoperative.	No
Secondary	Postoperative Throat Pain.		one hour postoperative	No