Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery

Respiratory Complication Clinical Trial

Official title:

Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010852
• Other study ID #: 16-1268
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients having planned elective bariatric surgery at University of Colorado Hospital

Exclusion Criteria:

• Emergency procedure
• Oxygen therapy within the previous 30 days
• Smoking within the previous 30 days
• Inability or refusal to provide consent

Related Conditions & MeSH terms

• Respiratory Complication

Intervention

Behavioral:
• Focused incentive spirometer education and monitoring

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of at least one episode of moderate/severe hypoxemic event		During first post operative day
Secondary	Duration of postoperative oxygen therapy	The duration of postoperative oxygen therapy will be evaluated from the arrival to the post-anesthesia care unit to successful discontinuation of oxygen therapy lasting greater than 2 hours.	Up to 7 days after surgery
Secondary	Presence of postoperative oxygen therapy and postoperative hypoxemic events	The development of postoperative hypoxemic events will be evaluated from the initiation of post-operative oxygen therapy through hospital discharge.	Up to 7 days after surgery