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OpenTrials
Completed

NCT Number: NCT03010852

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.

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Key information

Conditions

Respiratory Complication

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focused incentive spirometer education and monitoring

Behavioral

Primary outcomes

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

    Time frame: During first post operative day

Secondary outcomes

  1. Duration of postoperative oxygen therapy

    Time frame: 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.

  2. Presence of postoperative oxygen therapy and postoperative hypoxemic events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2017
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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