Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.

Official Title
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Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia

Conditions
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General Surgery

Intervention / Treatment
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* Other: 25° head-up position
* Other: 55° head-up position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status II-III patients Body Mass Index (BMI) of 40-60 Scheduled for an elective laparoscopic adjustable gastric band surgery Exclusion Criteria: Patients with abnormalities of the upper airway that require awake tracheal intubation Asthma Chronic obstructive pulmonary disease Pregnant patients

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A - 25° head-up position<br>Participants will be positioned at a 25° head-up position for procedure. | Other: 25° head-up position<br>* Angle person is positioned for procedure.<br>|
| Active Comparator: B - 55° head-up position<br>Participants will be positioned at a 55° head-up position for procedure. | Other: 55° head-up position<br>* Angle person is positioned for procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerable Apneic Time (TAT) | Measure of the TAT between groups to determine if the TAT is a function of the participant's position. | Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time to intubation (TTI) |  | Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes | 
| Peripheral arterial hemoglobin oxygen saturation (SpO2) trough | Measure of the rebound SpO2. It is the lowest SpO2 reading reached subsequent to start of mechanical ventilation at the SpO2 value of 94% and it represents final completion of SpO2 decline. | Time until SpO2 decreased to 92%, up to 8 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tolerable apneic time, bariatric surgery, gastric band surgery, intubation