Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery
Primary Purpose
Heart Diseases, Coronary Disease, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional prevention trial for Heart Diseases
Eligibility Criteria
Inclusion Criteria:
- High-risk patients underwent primary elective CABG (Coronary artery bypass graft), High-risk will be defined as 2 or more the following: age>70 years; cough and expectoration; diabetes; smoker; COPD (Chronic Obstructive Pulmonary Disease)
Exclusion Criteria:
- Uncontrolled arrhythmia,
- Decompensated heart failure,
- Unstable angina upon selection or during the inspiratory muscle training (IMT),
- Need for reoperation and association of another procedure during surgery (e.g. valve correction associated with CABG)
- Severe orthopedic or neurological conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inspiratory muscle training
Control group
Arm Description
Inspiratory muscle training with threshold device and workloud 30% of the peak inpiratory preassure, during two weeks prior to surgery, seven days a week, twice a day, three sets of ten repetitions with supervision.
Control group will receive a supportive educational component in the preoperative period.
Outcomes
Primary Outcome Measures
Postoperative Pulmonary Complications
The postoperative pulmonary complications (PPC) will be classified according to an ordinal scale from 1 to 4 , as proposed by Kroenke (2002).
The PPCs will be defined as clinically significant if the individual presented two or more Level 2 items or one or more Level 3 and/or 4 items. The Level 1 items were considered subclinical.
Secondary Outcome Measures
Respiratory Muscle Strenght
The respiratory muscle strength will be determined by means of a calibrated analogical manovacuometer, graded from -120 to +120cmH20, defining the maximum inspiratory and expiratory pressure (MIP and MEP). The MEP will be measured by the patient's maximum inflation of the lungs (total lung capacity), followed by a maximum forced expiration lasting 1 second. The maximum inspirator pressure (MIP) assessment will be carried out by the patient's maximum expiration, followed by a maximum inspiratory force lasting 1 second. At least three technically acceptable measurements will be carried out, presenting a difference of 10% or less among the values. The analysis considered the highest value (Neder, 1999; Hulzebous, 2006)
Functional Capacity
The functional capacity will be assessed by means of a 6-minute walk test (T6min) in accordance with the "American Thoracic Society - ATS" guidelines. Two tests will carried out, with a thirty minute interval between them, at a flat location inside the hospital. The 30 meter distance to be covered in a straight line will be marked with a measuring tape. The patient's performance will be assessed according to the longest distance covered (Holland et al, 2014)
Lenght of hospital stay hospitalization
The postoperative length of stay in hospital will be assessed by calculating the number of days the patient in the hospital from the day of the surgery until the hospital discharge authorized by the cardiology team physician.
Full Information
NCT ID
NCT03094923
First Posted
March 23, 2017
Last Updated
March 23, 2017
Sponsor
University of the State of Santa Catarina
1. Study Identification
Unique Protocol Identification Number
NCT03094923
Brief Title
Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery
Official Title
Effects of Preoperative Inspiratory Muscle Training on Functional Capacity and Pulmonary Complications in Coronary Artery Bypass Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 12, 2010 (Actual)
Primary Completion Date
March 17, 2011 (Actual)
Study Completion Date
January 18, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the State of Santa Catarina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on functional capacity, respiratory muscle strength, postoperative pulmonary complications and days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery (CABG).
Detailed Description
Patients undergoing coronary artery bypass graft surgery are at risk of postoperative pulmonary complications, which lead to increased postoperative morbidity and mortality.
A few studies have demonstrated that preoperative physical therapy has advantages over postoperative care in patients undergoing cardiac . In this way, this study aim to investigate the effects of preoperativeinspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Coronary Disease, Cardiovascular Diseases, Coronary Artery Occlusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training with threshold device and workloud 30% of the peak inpiratory preassure, during two weeks prior to surgery, seven days a week, twice a day, three sets of ten repetitions with supervision.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive a supportive educational component in the preoperative period.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Other Intervention Name(s)
Respiratory Muscle Training
Intervention Description
The inspiratory muscle training (IMT) will be carried out in the IG with Threshold® IMT (Respironics New Jersey, Inc) consisting of a unidirectional flow control valve which assures the constant resistance (linear load) between 7 and 41cmH20.
The IMT will be carried out in the sitting position with a load of 30% of the MIP during the two weeks preceding the surgery, seven days a week, twice daily in three series of ten repetitions with a 30 second interval between series, under the supervision of a physiotherapist. A load of 15% of the MIP was used only on the first day of training in order for the individual to adapt to the equipment. Subsequently, the 30% MIP load will be applied and readjusted according to the new MIP values determined every four days.
Primary Outcome Measure Information:
Title
Postoperative Pulmonary Complications
Description
The postoperative pulmonary complications (PPC) will be classified according to an ordinal scale from 1 to 4 , as proposed by Kroenke (2002).
The PPCs will be defined as clinically significant if the individual presented two or more Level 2 items or one or more Level 3 and/or 4 items. The Level 1 items were considered subclinical.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Respiratory Muscle Strenght
Description
The respiratory muscle strength will be determined by means of a calibrated analogical manovacuometer, graded from -120 to +120cmH20, defining the maximum inspiratory and expiratory pressure (MIP and MEP). The MEP will be measured by the patient's maximum inflation of the lungs (total lung capacity), followed by a maximum forced expiration lasting 1 second. The maximum inspirator pressure (MIP) assessment will be carried out by the patient's maximum expiration, followed by a maximum inspiratory force lasting 1 second. At least three technically acceptable measurements will be carried out, presenting a difference of 10% or less among the values. The analysis considered the highest value (Neder, 1999; Hulzebous, 2006)
Time Frame
1 month
Title
Functional Capacity
Description
The functional capacity will be assessed by means of a 6-minute walk test (T6min) in accordance with the "American Thoracic Society - ATS" guidelines. Two tests will carried out, with a thirty minute interval between them, at a flat location inside the hospital. The 30 meter distance to be covered in a straight line will be marked with a measuring tape. The patient's performance will be assessed according to the longest distance covered (Holland et al, 2014)
Time Frame
1 month
Title
Lenght of hospital stay hospitalization
Description
The postoperative length of stay in hospital will be assessed by calculating the number of days the patient in the hospital from the day of the surgery until the hospital discharge authorized by the cardiology team physician.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High-risk patients underwent primary elective CABG (Coronary artery bypass graft), High-risk will be defined as 2 or more the following: age>70 years; cough and expectoration; diabetes; smoker; COPD (Chronic Obstructive Pulmonary Disease)
Exclusion Criteria:
Uncontrolled arrhythmia,
Decompensated heart failure,
Unstable angina upon selection or during the inspiratory muscle training (IMT),
Need for reoperation and association of another procedure during surgery (e.g. valve correction associated with CABG)
Severe orthopedic or neurological conditions.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery
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