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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Respiratory Complication

Treatments

Behavioral: Focused incentive spirometer education and monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03010852
16-1268

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Standard of care incentive spirometer
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Behavioral: Focused incentive spirometer education and monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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