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

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.

Study Overview

• Status: Completed
• Conditions: General Surgery
• Intervention / Treatment: Other: 25° head-up position; Other: 55° head-up position

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Mirsad Dupanović, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: bariatric surgery; intubation; tolerable apneic time; gastric band surgery
• Other Study ID Numbers: 11506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No