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

Not Applicable

Completed

• Conditions: General Surgery
• Interventions: Other: 25° head-up position; Other: 55° head-up position

• Registration Number: NCT03056807
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2017-01-30
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-14
• Last Update Submitted: 2017-02-14
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - 25° head-up position	25° head-up position	Participants will be positioned at a 25° head-up position for procedure.
B - 55° head-up position	55° head-up position	Participants will be positioned at a 55° head-up position for procedure.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peripheral arterial hemoglobin oxygen saturation (SpO2) trough	Time until SpO2 decreased to 92%, up to 8 minutes	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.
Length of time to intubation (TTI)	Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States