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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
Sponsor:
Information provided by (Responsible Party):
Maria Ignez Zanetti Feltrim, University of Sao Paulo General Hospital

Brief Summary:

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

Detailed Description:
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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
level1
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®)

level2
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®)




Primary Outcome Measures :
  1. incidence of atelectasis [ Time Frame: Patients were followed for five days ]

Secondary Outcome Measures :
  1. pulmonary function [ Time Frame: Patients were followed for five days ]
    Forced vital capacity in liters and percentual (FVC; %FVC )

  2. pulmonary function [ Time Frame: Patients were followed for five days ]
    Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)

  3. pulmonary function [ Time Frame: Patients were followed for five days ]
    Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)


Other Outcome Measures:
  1. Respiratory Muscle Strength [ Time Frame: Patients were followed for five days ]
    Maximum inspiratory pressure (MIP)

  2. Respiratory Muscle Strength [ Time Frame: Patients were followed for five days ]
    Maximum expiratory pressure (MEP)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications of Results:
Other Publications:
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Responsible Party: Maria Ignez Zanetti Feltrim, Drª Maria Ignez Zanetti Feltrim, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02278835    
Other Study ID Numbers: CAPPesq 0011/09
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Maria Ignez Zanetti Feltrim, University of Sao Paulo General Hospital:
Cardiac valve