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Clinical Trials/NCT03010852
NCT03010852
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country60 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Complication
Sponsor
University of Colorado, Denver
Enrollment
60
Locations
1
Primary Endpoint
Frequency of at least one episode of moderate/severe hypoxemic event
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: During first post operative day

Secondary Outcomes

  • Presence of postoperative oxygen therapy and postoperative hypoxemic events(Up to 7 days after surgery)
  • Duration of postoperative oxygen therapy(Up to 7 days after surgery)

Study Sites (1)

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