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OPEP Device Treatment for Coronary Artery Bypass Surgery

N/A
Waitlist Available
Led By Philip M Jones, MD, MSc (Clinical Trials)
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion
Awards & highlights

Study Summary

Respiratory dysfunction following cardiac surgery is well documented and due in part to the location of the incision and nature of the surgery. Post-operative pulmonary complications (PPCs) remain a significant problem following cardiac surgery, sometimes causing prolonged length of stay in hospital as well as increased morbidity and mortality; with the greater risk to older adults and individuals with obstructive lung disease. Positive expiratory pressure (PEP) therapy is thought to increase lung volumes and facilitate secretion clearance. The purpose of this study is to investigate whether the addition of oscillating PEP therapy to standard postoperative treatment is more effective in decreasing the incidence of PPCs and increasing functional capacity at time of discharge in 'high risk' patients undergoing elective cardiac surgery.

Eligible Conditions
  • Aging Adults
  • Pulmonary Complications
  • Coronary Artery Bypass Surgery
  • Chronic Obstructive Pulmonary Disease
  • Cardiac Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6 Minute Walk Test (6MWT) Distance (meters)
Secondary outcome measures
All-cause 30-day mortality
Hospital LOS
Incidence of postoperative pulmonary complications (PPCs) as determined by CXR interpretation
+4 more
Other outcome measures
BiPAP usage
Borg shortness of breath scale
CPAP usage
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OPEP Device TreatmentExperimental Treatment1 Intervention
Patients randomized to OPEP will receive the device on postoperative day (POD) 1 or day of extubation, whichever comes first. Patients will be seen on POD #1 by a blinded physiotherapist (PT) for mobility and education on supported coughing. The OPEP device group will also be instructed to complete 15 breaths twice per waking hour in a seated position and receive education on proper use of the device. The OPEP device will be set to the highest pressure setting unless deemed inappropriate by the PT, at which time the most appropriate pressure setting will be selected and then increased daily until the OPEP device is set to the highest pressure setting by POD #3 if able. The PT will reassess the patients on POD 2 and 3 to assess for proper technique and continued use of the device, as well as usual care. Patients will use the OPEP device up to POD#5 pressure settings and compliance will be recorded and measure by use of a daily log.
Group II: SHAM DevicePlacebo Group1 Intervention
Patients randomized to the sham treatment will receive the sham device on postoperative day (POD) 1 or day of extubation, whichever comes first. Patients will be seen on POD #1 by a blinded physiotherapist (PT) for mobility and education on supported coughing. The sham group will also be instructed to complete 15 breaths twice per waking hour in a seated position and receive education on proper use of the device. The sham device is identical in exterior appearance to the OPEP device but does not contain the internal mechanism providing expiratory pressure. As such, the device will be set to the highest setting and will not need to be adjusted at all for patient tolerance. The PT will reassess the patients on POD 2 and 3 to assess for proper technique and continued use of the device, as well as usual care. Patients will use the OPEP device up to POD#5 pressure settings and compliance will be recorded and measure by use of a daily log.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,570 Total Patients Enrolled
Philip M Jones, MD, MSc (Clinical Trials)Principal InvestigatorWestern University, Canada

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery
Philip Jones 2016. "Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02732574.
~18 spots leftby Apr 2025
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