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

Not Applicable

Completed

• Conditions: Complications of Bariatric Procedures; Pneumonia; Pulmonary Atelectasis; Obesity, Morbid
• Interventions: Device: No incentive spirometer; Device: Incentive spirometer

• Registration Number: NCT02431455
• Lead Sponsor: Lahey Clinic

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.

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-01
• Study Start: 2015-06
• Results First Submitted: 2016-04-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Results First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Patients medically cleared to undergo bariatric surgery per the usual screening process

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Incentive Spirometry	No incentive spirometer	No incentive spirometer provided
Incentive Spirometry	Incentive spirometer	Incentive spirometry 10 times per hour while awake

Primary Outcome Measures

Name	Time	Method
Hypoxia 6 Hours Postoperative	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	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	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

Name	Time	Method
Postoperative Respiratory Complication	entire inpatient say, usually 1 to 7 days	atelectasis found on chest imaging, pneumonia, or re intubation

Trial Locations

Locations (1)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States