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.
Status | Not yet recruiting |
Enrollment | 162 |
Est. completion date | December 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University Hospital - London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of sham or OPEP device uses | Days 1 through 5 | No | |
Other | CPAP usage | Any patient who post-extubation requires CPAP therapy. | Up to postoperative day 7 | No |
Other | BiPAP usage | Any patient who post-extubation requires BiPAP therapy. | Up to postoperative day 7 | No |
Other | Re-intubation | Any patient who post-extubation requires re-intubation of the trachea. | Up to postoperative day 7 | No |
Other | Borg shortness of breath scale | During the postoperative six-minute walk test (on postoperative day 5 or discharge date, whichever comes first) | Through study completion | No |
Other | Fatigue scale while performing six minute walk test | The patient will assess their overall level of fatigue during the 6-min walk test on numeric rating scale (0 - not at all fatigued, 10 - maximally fatigued). During postoperative six minute walk test | Through study completion | No |
Primary | 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 | No |
Secondary | Total duration of oxygen therapy | Cumulative duration of oxygen therapy will be tracked and recorded for all patients, tracked from time of extubation until Postoperative day 7 or discharge, whichever comes first. | Time of tracheal extubation to Postoperative day 7 | No |
Secondary | Total exposure to oxygen therapy | The cumulative exposure to oxygen post-extubation will be tracked by calculating an area under the dose-time curve for oxygen usage, tracked from time of extubation until Postoperative day 7 or discharge, whichever comes first.. | From tracheal extubation until Postoperative day 7 | No |
Secondary | Number of cycles between room air and oxygen supplementation | Each time someone goes from room air to back on oxygen, this is a setback, and we will count this one 'cycle', tracked from time of extubation until Postoperative day 7 or discharge, whichever comes first.. | From tracheal extubation until Postoperative day 7 | No |
Secondary | Incidence of postoperative pulmonary complications (PPCs) as determined by CXR interpretation | Incidence of PPCs will be assessed by a blinded assessor. PPCs will include: pneumonia/consolidation atelectasis pleural effusions pulmonary edema pneumothorax. Presence of each PPC will be expressed as a 3 point score: 0= absent, 1=mild (not likely clinically relevant), 2 = moderate to severe (likely clinically relevant). |
Postoperative days 1 and 4 | No |
Secondary | Intensive Care Unit (ICU) length of stay (LOS) | time from admission to ICU (time 0) until actual discharge from ICU | Through study completion | No |
Secondary | Hospital LOS | Time from admission to ICU until actual discharge from hospital | Through study completion | No |
Secondary | All-cause 30-day mortality | This will be determined by hospital records, a phone call to family physician (if available) or by phone call to patient or substitute decision maker. | Up to and including the 30th post-operative day | Yes |
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