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

NCT02732574 | Unknown

• 1 other identifier: OPEP-2016
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test (6MWT) Distance (meters)

  A 6MWT will be conducted as per American Thoracic Society guidelines in a designated hallway in the basement of university hospital or a corridor outside the cardiac surgery recovery unit. The tests will be conducted by a blinded assessor pre-operatively and on Postoperative day 5 or day of discharge, whichever comes first. Distance walked in meters will be recorded.

  Postoperative day 5

Secondary Outcomes (7)

• Total duration of oxygen therapy

  Time of tracheal extubation to Postoperative day 7

• Total exposure to oxygen therapy

  From tracheal extubation until Postoperative day 7

• Number of cycles between room air and oxygen supplementation

  From tracheal extubation until Postoperative day 7

• Incidence of postoperative pulmonary complications (PPCs) as determined by CXR interpretation

  Postoperative days 1 and 4

• Intensive Care Unit (ICU) length of stay (LOS)

  Through study completion

Other Outcomes (6)

• Number of sham or OPEP device uses

  Days 1 through 5

• CPAP usage

  Up to postoperative day 7

• BiPAP usage

  Up to postoperative day 7

Study Arms (2)

OPEP Device Treatment

EXPERIMENTAL

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.

Device: Oscilatory Positive Expiratory Pressure (OPEP) device

SHAM Device

SHAM COMPARATOR

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.

Device: SHAM Device Group

Interventions

Oscilatory Positive Expiratory Pressure (OPEP) device 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.

Also known as: Aerobika

OPEP Device Treatment

SHAM Device Group DEVICE

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.

SHAM Device

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CABG surgery or CABG-one valve (mitral or aortic) surgery (including conventional sternotomy on cardiopulmonary bypass, minimally-invasive and off-pump surgery)
• Age \>= 60 years
• Documentation of at least one of the following: (pre-operative fraction of expired volume in one second (FEV1) of less than 70% predicted), (pre-operative FEV1/forced vital capacity (FVC) of less than 80%), or (on any daily usage of inhaled anti-cholinergic, beta2-agonist, or corticosteroid)
• New York Heart Association (NYHA) ≥ 2

You may not qualify if:

• Unable/unwilling to provide written informed consent
• Patients undergoing emergent cardiac surgery
• Untreated postoperative pneumothorax
• Patients on home CPAP or BiPAP therapy

Sponsors & Collaborators

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

Study Sites (1)

University Hospital - London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip M Jones, MD, MSc (Clinical Trials)

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Fox, BA, RRT

CONTACT

519-685-8500; stephanie.fox@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 8, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

CA (1)