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

NCT03010852 | Completed

• 1 other identifier: 16-1268
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Complication

Keywords

Bariatric Surgery; Spirometry Monitoring

Outcome Measures

Primary Outcomes (1)

• Frequency of at least one episode of moderate/severe hypoxemic event

  During first post operative day

Secondary Outcomes (2)

• Duration of postoperative oxygen therapy

  Up to 7 days after surgery

• Presence of postoperative oxygen therapy and postoperative hypoxemic events

  Up to 7 days after surgery

Study Arms (2)

Standard of care incentive spirometer

NO INTERVENTION

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.

Focused incentive spirometer education and monitoring

EXPERIMENTAL

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

Interventions

Focused incentive spirometer education and monitoring BEHAVIORAL

Focused incentive spirometer education and monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Officials

• Ana Fernandez-Bustamante, M.D., Ph.D.

  University of Colorado, School of Medicine - Department of Anesthesology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: January 5, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)