The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Disease
• Intervention / Treatment: Other: breathing exercises; Device: incentive spirometry; Device: Intermittent positive pressure breathing; Device: Continuous positive airway pressure

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 .

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: EXE; Device: incentive spirometry; 3 sets of 10 repetitions of deep breathing exercises with incentive spirometry; Other Names: IS (Coach®)
Other: 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 Names: IPPB (BIRD Mark 7™); Device: Continuous positive airway pressure; 20 minutes breathing with continuous positive airway pressure; Other Names: CPAP (Sullivan®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of atelectasis	Patients were followed for five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary function	Forced vital capacity in liters and percentual (FVC; %FVC )	Patients were followed for five days
pulmonary function	Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)	Patients were followed for five days
pulmonary function	Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)	Patients were followed for five days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Muscle Strength	Maximum inspiratory pressure (MIP)	Patients were followed for five days
Respiratory Muscle Strength	Maximum expiratory pressure (MEP)	Patients were followed for five days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 29, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac valve
• Other Study ID Numbers: CAPPesq 0011/09