The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

University of Sao Paulo General Hospital

Status: Completed

Conditions: Mitral Valve Disease

Treatments: Device: incentive spirometry; Other: breathing exercises; Device: Continuous positive airway pressure; Device: Intermittent positive pressure breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT02278835

CAPPesq 0011/09

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

level1

Other group

Description:

Patients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group

Treatment:

Other: breathing exercises

Device: incentive spirometry

level2

Other group

Description:

Patients classified in level 2 were randomized in the Intermittent Positive Pressure Breathing group or Continuous Positive Airway Pressure group

Treatment:

Device: Intermittent positive pressure breathing

Device: Continuous positive airway pressure