The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

NCT ID: NCT02278835

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-09-30

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 .

Conditions

Mitral Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

level1

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

Group Type: OTHER

breathing exercises

Intervention Type: OTHER

3 sets of 10 repetitions of deep breathing exercises

incentive spirometry

Intervention Type: DEVICE

3 sets of 10 repetitions of deep breathing exercises with incentive spirometry

level2

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

Group Type: OTHER

Intermittent positive pressure breathing

Intervention Type: DEVICE

20 minutes breathing with intermittent positive pressure

Continuous positive airway pressure

Intervention Type: DEVICE

20 minutes breathing with continuous positive airway pressure

Interventions

breathing exercises

3 sets of 10 repetitions of deep breathing exercises

Intervention Type: OTHER

incentive spirometry

3 sets of 10 repetitions of deep breathing exercises with incentive spirometry

Intervention Type: DEVICE

Intermittent positive pressure breathing

20 minutes breathing with intermittent positive pressure

Intervention Type: DEVICE

Continuous positive airway pressure

20 minutes breathing with continuous positive airway pressure

Intervention Type: DEVICE

Other Intervention Names

EXE; IS (Coach®); IPPB (BIRD Mark 7™); CPAP (Sullivan®)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Ignez Zanetti Feltrim

Drª Maria Ignez Zanetti Feltrim

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Matte P, Jacquet L, Van Dyck M, Goenen M. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2000 Jan;44(1):75-81. doi: 10.1034/j.1399-6576.2000.440114.x.

Reference Type: BACKGROUND

PMID: 10669276 (View on PubMed)

Pasquina P, Tramer MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003 Dec 13;327(7428):1379. doi: 10.1136/bmj.327.7428.1379.

Reference Type: RESULT

PMID: 14670881 (View on PubMed)

Other Identifiers

CAPPesq 0011/09

Identifier Type: -

Identifier Source: org_study_id