Clinical trial NCT02732574: Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery
Official title: The Effectiveness of Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Coronary Artery Bypass Grafting
Chronic Obstructive Pulmonary Disease (COPD)
Older Adults
Postoperative Pulmonary Complications
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 162
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Respiratory dysfunction following cardiac surgery is well documented and due in part to the location of the incision and nature of the surgery (Weissman, 2000; Garcia-Delgado M, et al., 2014). Patients undergoing cardiac surgery are at an increased risk of postoperative pulmonary complications including hypoxemia, atelectasis, and pneumonia (Weissman, 2000; Garcia-Delgado M, et al., 2014; O'Donohue WJ, 1992); with an increased risk in older individuals and individuals with obstructive lung disease (Crowe \& Bradley, 1997; Weissman 2000; Jensen et al., 2007). Standard postoperative care includes early mobility and deep breathing and coughing (DB\&C) (Stiller K, et al., 1995; Johnson D., et al., 1996) usually initiated within the first 24 hours following surgery. Although standard care is sufficient in some instances, postoperative pulmonary complications (PPCs) remain a significant problem following cardiac surgery and can cause prolonged length of stay in the hospital and an increase in morbidity and mortality (Weissman, 2000; Garcia-Delgado M, et al., 2014) in a significant number of patients. Positive expiratory pressure (PEP) therapy is thought to increase lung volumes and facilitate secretion clearance in many populations (Orman J \& Wasterdahl E, 2009) and has been shown to be particularly effective in individuals with obstructive lung disease (Bott et al ., 2009). In consideration of the well documented respiratory dysfunction observed following cardiac surgery, PEP therapy may serve as a promising treatment in facilitating recovery in older, 'higher risk' individuals following elective cardiac surgery. Thus, the purpose of this study is to investigate whether the addition of oscillating PEP therapy is more effective than standard treatment alone in improving functional status at time of discharge, as well as decreasing oxygen requirements and the incidence of postoperative pulmonary complications (e.g., pneumonia, atelectasis, pneumothorax, pleural effusions) in 'high risk' patients undergoing elective cardiac surgery.

Participants will be recruited from London Health Sciences Centre in London Ontario. Patients deciding to proceed with elective cardiac surgery will be screened in the surgeon's office, pre-admission clinic or the 6-inpatient ward for eligibility to participate in the study and provided with a letter of information. Each patient will be required to provide written consent in order to participate in this study. The study will be approved by the Health Sciences Research Ethics Board at Western University. Patients who have consented to participation in the study will be seen by the research coordinator at the patient's pre-operative clinic appointment where the research coordinator will explain the purpose and nature of the study and obtain written informed consent. Also, at that time, patient demographic information will be collected, as well as baseline data of chest x-ray (CXR) and a six minute walk test (6MWT). Pre-operative 6MWTs will be performed on a standardized 30 meter track in the basement of University Hospital and will comply with the American Thoracic Society Guidelines (2002). Patients enrolled in the study will be randomized to one of two groups on the day of their surgery; OPEP treatment or sham treatment group. On the day of surgery or post-operative day (POD) 1, the research coordinator will bring the device (OPEP or sham depending on randomization) to the patient's room. The sham devices have been manufactured to be externally identical to the OPEP devices allowing for patient blinding, however the sham devices do not contain the internal mechanisms provided expiratory pressure. All patients (sham or OPEP) will be seen by a physiotherapist on the day of extubation and receive instructions on how to properly use the device, in addition to receiving standard post-operative care. Patients will be instructed to set the resistance on the device to the highest setting and perform up to 15 breaths in the sitting position at least twice per waking hour. The resistance and number of repetitions may be decreased to adjust for patient tolerance as deemed appropriate by the treating physiotherapist. Compliance will be measured through a log book completed by the patient and/or their family. Patients will be reassessed by a physiotherapist on POD #2 and #3 to ensure proper technique and compliance with the device. All patients will continue to receive standard care each day as per the clinical pathway and may receive additional cardiorespiratory PT techniques as deemed necessary by the PT. Patients will be instructed to continue with OPEP treatments (sham or OPEP) as described until POD #5. Outcome assessment will be conducted by a blinded assessor. The outcomes and timing of outcome assessment is described in the outcome measures section and will terminate on POD #7 or discharge from hospital, whichever occurs first. If patients require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), or reintubation during this period, they will be instructed to stop using their OPEP device and outcome assessment will occur only until POD#7.

Eligibility criteria: Undergoing elective or urgent coronary artery bypass grafting (CABG) surgery at London Health Sciences Centre and satisfying the following criteria:

Inclusion Criteria:

* 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

Exclusion criteria:

* Patients not meeting inclusion for high risk surgical candidate
* Unable/unwilling to provide written informed consent
* Patients undergoing emergent cardiac surgery
* Untreated postoperative pneumothorax
* Patients on home CPAP or BiPAP therapy

Primary outcomes:
measure: 6 Minute Walk Test (6MWT) Distance (meters)
timeFrame: Postoperative day 5
Secondary outcomes:
measure: Total duration of oxygen therapy
timeFrame: Time of tracheal extubation to Postoperative day 7
measure: Total exposure to oxygen therapy
timeFrame: From tracheal extubation until Postoperative day 7
measure: Number of cycles between room air and oxygen supplementation
timeFrame: From tracheal extubation until Postoperative day 7
measure: Incidence of postoperative pulmonary complications (PPCs) as determined by CXR interpretation
timeFrame: Postoperative days 1 and 4
measure: Intensive Care Unit (ICU) length of stay (LOS)
timeFrame: Through study completion
measure: Hospital LOS
timeFrame: Through study completion
measure: All-cause 30-day mortality
timeFrame: Up to and including the 30th post-operative day
Other outcomes:
measure: Number of sham or OPEP device uses
timeFrame: Days 1 through 5
measure: CPAP usage
timeFrame: Up to postoperative day 7
measure: BiPAP usage
timeFrame: Up to postoperative day 7
measure: Re-intubation
timeFrame: Up to postoperative day 7
measure: Borg shortness of breath scale
timeFrame: Through study completion
measure: Fatigue scale while performing six minute walk test
timeFrame: Through study completion
Locations:
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Philip M Jones, MD, MSc (Clinical Trials)
role: PRINCIPAL_INVESTIGATOR
References: