The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

Study Overview
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Brief Summary
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This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge. Patients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence. The group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions. Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2 <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon. All of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.

Detailed Description
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The study were conducted with individuals of both gender, aged between 18 and 60 years, candidates for mitral valve surgery, up to a maximum 2nd valve replacement. Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours .

Official Title
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To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve

Conditions
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Mitral Valve Disease

Intervention / Treatment
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* Other: breathing exercises
* Device: incentive spirometry
* Device: Intermittent positive pressure breathing
* Device: Continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients for mitral valve surgery, up to a maximum 2nd valve replacement Exclusion Criteria: Patients unable to perform the functional tests Patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: level1<br>Patients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group | Other: breathing exercises<br>* 3 sets of 10 repetitions of deep breathing exercises<br>* Other names: EXE;Device: incentive spirometry<br>* 3 sets of 10 repetitions of deep breathing exercises with incentive spirometry<br>* Other names: IS (Coach®);|
| Other: level2<br>Patients classified in level 2 were randomized in the Intermittent Positive Pressure Breathing group or Continuous Positive Airway Pressure group | Device: Intermittent positive pressure breathing<br>* 20 minutes breathing with intermittent positive pressure<br>* Other names: IPPB (BIRD Mark 7™);Device: Continuous positive airway pressure<br>* 20 minutes breathing with continuous positive airway pressure<br>* Other names: CPAP (Sullivan®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of atelectasis |  | Patients were followed for five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function | Forced vital capacity in liters and percentual (FVC; %FVC ) | Patients were followed for five days | 
| pulmonary function | Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1) | Patients were followed for five days | 
| pulmonary function | Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC) | Patients were followed for five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac valve