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Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery

NCT02732574 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2016-09-15

No results posted yet for this 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.

Conditions

  • Cardiac Surgery
  • Coronary Artery Bypass Grafting
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Older Adults
  • Postoperative Pulmonary Complications

Interventions

DEVICE

Oscilatory Positive Expiratory Pressure (OPEP) device

OPEP devices will be set to the highest pressure setting tolerated on POD #1. If the highest pressure setting is not achieved on POD#1, the PT will increase the pressure daily with the aim to achieve the highest pressure setting as soon as tolerated by the patient or POD#3, whichever comes first. Patients will be instructed to complete 15 breaths in a seated position with the OPEP device twice per waking hour. This will occur in addition to usual care.

DEVICE

SHAM Device Group

SHAM devices will be provided to patients on POD #1 and set to the highest pressure setting externally, however no positive expiratory pressure will be provided as the internal pressure regulating mechanism has been removed. Patients will be instructed to complete 15 breaths in a seated position with the sham device twice per waking hour. This will occur in addition to usual care.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Philip M Jones, MD, MSc (Clinical Trials) · Western University, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-09-30
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02732574 on ClinicalTrials.gov