Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedFebruary 17, 2017
February 1, 2017
2.8 years
January 30, 2017
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Time until SpO2 decreased to 92%, up to 8 minutes
Study Arms (2)
A - 25° head-up position
ACTIVE COMPARATORParticipants will be positioned at a 25° head-up position for procedure.
B - 55° head-up position
ACTIVE COMPARATORParticipants will be positioned at a 55° head-up position for procedure.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with abnormalities of the upper airway that require awake tracheal intubation
- Asthma
- Chronic obstructive pulmonary disease
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mirsad Dupanović, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The person measuring and recording the study data ("timer") will be blinded.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
February 17, 2017
Study Start
October 1, 2008
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 17, 2017
Record last verified: 2017-02