The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

NCT02278835 | Completed

• 1 other identifier: CAPPesq 0011/09
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Valve Disease

Keywords

Cardiac valve

Outcome Measures

Primary Outcomes (1)

• incidence of atelectasis

  Patients were followed for five days

Secondary Outcomes (3)

• pulmonary function

  Patients were followed for five days

• pulmonary function

  Patients were followed for five days

• pulmonary function

  Patients were followed for five days

Other Outcomes (2)

• Respiratory Muscle Strength

  Patients were followed for five days

• Respiratory Muscle Strength

  Patients were followed for five days

Study Arms (2)

level1

OTHER

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

Other: breathing exercises; Device: incentive spirometry

level2

OTHER

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; Device: Continuous positive airway pressure

Interventions

breathing exercises OTHER

3 sets of 10 repetitions of deep breathing exercises

Also known as: EXE

level1

incentive spirometry DEVICE

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

Also known as: IS (Coach®)

level1

Intermittent positive pressure breathing DEVICE

20 minutes breathing with intermittent positive pressure

Also known as: IPPB (BIRD Mark 7™)

level2

Continuous positive airway pressure DEVICE

20 minutes breathing with continuous positive airway pressure

Also known as: CPAP (Sullivan®)

level2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients for mitral valve surgery, up to a maximum 2nd valve replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related 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. doi: 10.1034/j.1399-6576.2000.440114.x.

  PMID: 10669276 BACKGROUND

• 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.

  PMID: 14670881 RESULT

MeSH Terms

Interventions

Breathing Exercises; Intermittent Positive-Pressure Breathing; Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drª Maria Ignez Zanetti Feltrim

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 30, 2014
• Study Start: March 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10