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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbidly Obese, Intubationtime, Intubationattempts

Intervention / Treatment
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* Device: GlideScope
* Device: Fastrach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >/= 35 Exclusion Criteria: need for crash induction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fastrach<br>50 persons beeing intubated using the Fastrach. | Device: Fastrach<br>* The Fastrach is an intubation laryngeal mask.<br>|
| Experimental: GlideScope<br>50 persons beeing intubated using the GlideScope. | Device: GlideScope<br>* The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to Intubate |  | From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |