search
Back to results

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
University of the State of Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Diseases

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 23, 2017
    Last Updated
    March 23, 2017
    Sponsor
    University of the State of Santa Catarina
    search

    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

    We'll reach out to this number within 24 hrs