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Clinical Trials/NCT02278835
NCT02278835
Completed
N/A

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

University of Sao Paulo General Hospital0 sites110 target enrollmentMarch 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mitral Valve Disease
Sponsor
University of Sao Paulo General Hospital
Enrollment
110
Primary Endpoint
incidence of atelectasis
Status
Completed
Last Updated
11 years ago

Overview

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.

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 .

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Ignez Zanetti Feltrim

Drª Maria Ignez Zanetti Feltrim

University of Sao Paulo General Hospital

Eligibility 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

Outcomes

Primary Outcomes

incidence of atelectasis

Time Frame: Patients were followed for five days

Secondary Outcomes

  • pulmonary function(Patients were followed for five days)

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