The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery

Conditions
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Obesity, Morbid, Complications of Bariatric Procedures, Pulmonary Atelectasis, Pneumonia

Intervention / Treatment
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* Device: Incentive spirometer
* Device: No incentive spirometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients medically cleared to undergo bariatric surgery per the usual screening process Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Incentive Spirometry<br>Incentive spirometry 10 times per hour while awake | Device: Incentive spirometer<br>* Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.<br>* Other names: Control;|
| Experimental: No Incentive Spirometry<br>No incentive spirometer provided | Device: No incentive spirometer<br>* No incentive spirometer is provided to the patient, this is the study arm.<br>* Other names: Study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Respiratory Complication | atelectasis found on chest imaging, pneumonia, or re intubation | entire inpatient say, usually 1 to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, obesity, morbid, incentive spirometry