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

Not Applicable

Completed

• Conditions: Respiratory Complication
• Interventions: Behavioral: Focused incentive spirometer education and monitoring

• Registration Number: NCT03010852
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2020-08
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused incentive spirometer education and monitoring	Focused incentive spirometer education and monitoring	One of the study investigators will meet eligible patients in the preoperative visit to the UCH Weight Loss Surgery clinic, inform and consent the patient and introduce the first education on IS therapy, highlighting its possible benefits and the importance of compliance (patient's inspiratory effort and frequency). This IS education will be repeated in the preoperative area immediately before surgery. The site will then follow the patient postoperatively. The site will directly check on the patient in the PACU and later in his/her hospital room at least 3 times a day during the first 3 days or sooner if their O2 therapy is discontinued for 2h. During these PO check ups The site will reinforce the IS use, monitor the patient's performance of IS and ask him/her about other respiratory symptoms.

Primary Outcome Measures

Name	Time	Method
Frequency of at least one episode of moderate/severe hypoxemic event	During first post operative day

Secondary Outcome Measures

Name	Time	Method
Presence of postoperative oxygen therapy and postoperative hypoxemic events	Up to 7 days after surgery	The development of postoperative hypoxemic events will be evaluated from the initiation of post-operative oxygen therapy through hospital discharge.
Duration of postoperative oxygen therapy	Up to 7 days after surgery	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States