The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
NCT ID: NCT02431455
Last Updated: 2016-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
224 participants
INTERVENTIONAL
2015-06-30
2016-05-31
Brief Summary
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Detailed Description
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This study aims to examine the effect of incentive spirometry after bariatric surgery by performing a prospective randomized trial. Subjects will be randomized to either receive an incentive spirometer or not. The primary outcome measure of oxygen saturation off of supplemental oxygen will be taken preoperatively and at 6,12, and 24 hours postoperatively. Secondary outcome measures include rate of pulmonary complications, and time to wean off of supplemental oxygen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Incentive Spirometry
Incentive spirometry 10 times per hour while awake
Incentive spirometer
Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
No Incentive Spirometry
No incentive spirometer provided
No incentive spirometer
No incentive spirometer is provided to the patient, this is the study arm.
Interventions
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Incentive spirometer
Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
No incentive spirometer
No incentive spirometer is provided to the patient, this is the study arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Lahey Clinic
OTHER
Responsible Party
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Dmitry Nepomnayshy
Assistant Professor of Surgery TUFTS Medical School
Principal Investigators
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Dmitry Nepomnayshy, MD
Role: PRINCIPAL_INVESTIGATOR
Lahey Clinic General Surgery
Locations
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Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Countries
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References
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Pantel H, Hwang J, Brams D, Schnelldorfer T, Nepomnayshy D. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 May 1;152(5):422-428. doi: 10.1001/jamasurg.2016.4981.
Other Identifiers
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2015-019
Identifier Type: -
Identifier Source: org_study_id
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