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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03056807
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
General Surgery	Other: 25° head-up position; Other: 55° head-up position	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The person measuring and recording the study data ("timer") will be blinded.
• Primary Purpose: Health Services Research
• Official Title: Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia
• Actual Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Length of time to intubation (TTI) [Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes]

2. 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.

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03056807
• Other Study ID Numbers: 11506
• First Posted: Feb 17, 2017
• Last Update Posted: Feb 17, 2017
• Last Verified: Feb 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Kansas Medical Center: tolerable apneic time; bariatric surgery; gastric band surgery; intubation

Study Results

No Results Posted as of Feb 17, 2017