Cardiac Surgery Clinical Trial
Official title:
The Effectiveness of Oscillating Positive Expiratory Pressure (OPEP) Therapy in High Risk Patients Following Cardiac Surgery Surgery: A Randomized Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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