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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02431455
• Other study ID #: 2015-019
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: July 14, 2015
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2015
• Source: Lahey Clinic
• Contact: Haddon J Pantel, MD
• Phone: 781-744-8585
• Email: Haddon.Pantel[@]lahey.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoxia 6 hours postoperative	percentage 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	No
Primary	hypoxia 12 hours postoperative	percentage 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	No
Primary	hypoxia 24 hours postoperative	percentage 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	No
Secondary	postoperative respiratory complication	atelectasis found on chest imaging, pneumonia, or re intubation	entire inpatient say, usually 1 to 7 days	No
Secondary	time to wean off supplemental oxygen	time to wean off supplemental oxygen based on current inpatient nursing protocols	entire inpatient say, usually 1 to 7 days	No
Secondary	oxygen saturation at 6 hours postoperative	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	No
Secondary	oxygen saturation at 12 hours postoperative	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	No
Secondary	oxygen saturation at 24 hours postoperative	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	No