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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Complication
• Intervention / Treatment: Behavioral: Focused incentive spirometer education and monitoring

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care incentive spirometer; Patients in the SOC cohort will not receive the preoperative education and only one postoperative visit per day to collect their self-reported use of IS, if prescribed, and respiratory symptoms but avoiding increasing their awareness of POH, O2 therapy and IS.
Experimental: 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.	Behavioral: Focused incentive spirometer education and monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of at least one episode of moderate/severe hypoxemic event	During first post operative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ana Fernandez-Bustamante, M.D., Ph.D., University of Colorado, School of Medicine - Department of Anesthesology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Spirometry Monitoring
• Other Study ID Numbers: 16-1268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: N/A IPD will not be shared with other researchers