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

• ClinicalTrials.gov Identifier: NCT01237080
• Recruitment Status: Completed
• First Posted: November 9, 2010
• Results First Posted: February 20, 2013
• Last Update Posted: February 20, 2013
• Sponsor: Glostrup University Hospital, Copenhagen
• Information provided by (Responsible Party): Mogens Ydemann Nielsen, Glostrup University Hospital, Copenhagen

Study Description

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®.

Condition or disease	Intervention/treatment	Phase
Morbidly Obese; Intubationtime; Intubationattempts	Device: GlideScope; Device: Fastrach	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.
• Study Start Date: September 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fastrach; 50 persons beeing intubated using the Fastrach.	Device: Fastrach; The Fastrach is an intubation laryngeal mask.
Experimental: GlideScope; 50 persons beeing intubated using the GlideScope.	Device: GlideScope; The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Intubated in the First Attempt [ Time Frame: 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).
2. Time to Intubate [ Time Frame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph. ]

Secondary Outcome Measures :

1. Lowest Saturation During Intubation. [ Time Frame: measured on the monitor ]
2. Mucosal Lesion [ Time Frame: inspection during intubation and one hour postop. ]
3. Subjectively Intubation Difficulty [ Time Frame: measured immediately on a visual analogue scale. ]
4. Intubation of the Esophagus. [ Time Frame: detected immediately ]
5. Postoperative Hoarseness. [ Time Frame: one hour postoperative. ]
6. Postoperative Throat Pain. [ Time Frame: one hour postoperative ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• BMI >/= 35

Exclusion Criteria:

• need for crash induction.

Contacts and Locations

Locations

Denmark

Department of Anesthesiology, Copenhagen University Hospital

Glostrup, Zeeland, Denmark, 2600

Privathospitalet Hamlet

Soeborg, Zeeland, Denmark, 2860

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen

Investigators

• Principal Investigator: Mogens VY Nielsen, MD; Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark

More Information

• Responsible Party: Mogens Ydemann Nielsen, MD, Glostrup University Hospital, Copenhagen
• ClinicalTrials.gov Identifier: NCT01237080
• Other Study ID Numbers: H-1-2010-058
• First Posted: November 9, 2010
• Results First Posted: February 20, 2013
• Last Update Posted: February 20, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight