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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732574
• Other study ID #: OPEP-2016
• Status: Not yet recruiting
• Phase: N/A
• First received: March 27, 2016
• Last updated: September 14, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: Stephanie Fox, BA, RRT
• Phone: 519-685-8500
• Email: stephanie.fox[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University Hospital - London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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