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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056807
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
General Surgery Other: 25° head-up position Other: 55° head-up position Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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.




Primary Outcome Measures :
  1. Tolerable Apneic Time (TAT) [ Time Frame: 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 Frame: 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 Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056807


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Mirsad Dupanović, MD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03056807    
Other Study ID Numbers: 11506
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

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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