The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery
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|ClinicalTrials.gov Identifier: NCT02278835|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Disease||Other: breathing exercises Device: incentive spirometry Device: Intermittent positive pressure breathing Device: Continuous positive airway pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||September 2014|
Patients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group
Other: breathing exercises
3 sets of 10 repetitions of deep breathing exercises
Other Name: EXE
Device: incentive spirometry
3 sets of 10 repetitions of deep breathing exercises with incentive spirometry
Other Name: IS (Coach®)
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
20 minutes breathing with intermittent positive pressure
Other Name: IPPB (BIRD Mark 7™)
Device: Continuous positive airway pressure
20 minutes breathing with continuous positive airway pressure
Other Name: CPAP (Sullivan®)
- incidence of atelectasis [ Time Frame: Patients were followed for five days ]
- pulmonary function [ Time Frame: Patients were followed for five days ]Forced vital capacity in liters and percentual (FVC; %FVC )
- pulmonary function [ Time Frame: Patients were followed for five days ]Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)
- pulmonary function [ Time Frame: Patients were followed for five days ]Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)
- Respiratory Muscle Strength [ Time Frame: Patients were followed for five days ]Maximum inspiratory pressure (MIP)
- Respiratory Muscle Strength [ Time Frame: Patients were followed for five days ]Maximum expiratory pressure (MEP)