The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278835
• Other study ID #: CAPPesq 0011/09
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: October 29, 2014
• Start date: March 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases
• Mitral Valve Disease

Intervention

Other:
• breathing exercises
3 sets of 10 repetitions of deep breathing exercises

Device:
• incentive spirometry
3 sets of 10 repetitions of deep breathing exercises with incentive spirometry
• Intermittent positive pressure breathing
20 minutes breathing with intermittent positive pressure
• Continuous positive airway pressure
20 minutes breathing with continuous positive airway pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (2)

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. — View Citation

Pasquina P, Tramèr MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003 Dec 13;327(7428):1379. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory Muscle Strength	Maximum inspiratory pressure (MIP)	Patients were followed for five days	Yes
Other	Respiratory Muscle Strength	Maximum expiratory pressure (MEP)	Patients were followed for five days	Yes
Primary	incidence of atelectasis		Patients were followed for five days	Yes
Secondary	pulmonary function	Forced vital capacity in liters and percentual (FVC; %FVC )	Patients were followed for five days	Yes
Secondary	pulmonary function	Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)	Patients were followed for five days	Yes
Secondary	pulmonary function	Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)	Patients were followed for five days	Yes