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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03010852

Enrollment

Registered

2017-01-05

Start date

2016-07-31

Completion date

2020-12-31

Last updated

2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Complication

Keywords

Bariatric Surgery, Spirometry Monitoring

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.

Interventions

BEHAVIORALFocused incentive spirometer education and monitoring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026