Back to resultsThe Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
Primary Purpose
Obesity, Morbid, Complications of Bariatric Procedures, Pulmonary Atelectasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentive spirometer
No incentive spirometer
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Bariatric Surgery, obesity, morbid, incentive spirometry
Eligibility Criteria
Inclusion Criteria:
- Patients medically cleared to undergo bariatric surgery per the usual screening process
Exclusion Criteria:
- None
Sites / Locations
- Lahey Hospital & Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Incentive Spirometry
No Incentive Spirometry
Arm Description
Incentive spirometry 10 times per hour while awake
No incentive spirometer provided
Outcomes
Primary Outcome Measures
Hypoxia 6 Hours Postoperative
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.
Hypoxia 12 Hours Postoperative
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.
Hypoxia 24 Hours Postoperative
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.
Secondary Outcome Measures
Postoperative Respiratory Complication
atelectasis found on chest imaging, pneumonia, or re intubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02431455
Brief Title
The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
Official Title
The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.
Detailed Description
Incentive spirometry is speculated to improve pulmonary function in the postoperative period, though data to support this is lacking. Patients undergoing bariatric surgery are at increased risk for pulmonary compromise as they are obese and undergoing foregut surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Complications of Bariatric Procedures, Pulmonary Atelectasis, Pneumonia
Keywords
Bariatric Surgery, obesity, morbid, incentive spirometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incentive Spirometry
Arm Type
Active Comparator
Arm Description
Incentive spirometry 10 times per hour while awake
Arm Title
No Incentive Spirometry
Arm Type
Experimental
Arm Description
No incentive spirometer provided
Intervention Type
Device
Intervention Name(s)
Incentive spirometer
Other Intervention Name(s)
Control
Intervention Description
Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
Intervention Type
Device
Intervention Name(s)
No incentive spirometer
Other Intervention Name(s)
Study
Intervention Description
No incentive spirometer is provided to the patient, this is the study arm.
Primary Outcome Measure Information:
Title
Hypoxia 6 Hours Postoperative
Description
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.
Time Frame
6 hours postoperative
Title
Hypoxia 12 Hours Postoperative
Description
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.
Time Frame
12 hours postoperative
Title
Hypoxia 24 Hours Postoperative
Description
Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative Respiratory Complication
Description
atelectasis found on chest imaging, pneumonia, or re intubation
Time Frame
entire inpatient say, usually 1 to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients medically cleared to undergo bariatric surgery per the usual screening process
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Nepomnayshy, MD
Organizational Affiliation
Lahey Clinic General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28097332
Citation
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.
Results Reference
derived
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The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
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