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The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02278835
Enrollment
110
Registered
2014-10-30
Start date
2009-03-31
Completion date
2014-09-30
Last updated
2014-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Disease

Keywords

Cardiac valve

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 .

Interventions

OTHERbreathing exercises

3 sets of 10 repetitions of deep breathing exercises

DEVICEincentive spirometry

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

20 minutes breathing with intermittent positive pressure

DEVICEContinuous positive airway pressure

20 minutes breathing with continuous positive airway pressure

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incidence of atelectasisPatients were followed for five days

Secondary

MeasureTime frameDescription
pulmonary functionPatients were followed for five daysForced vital capacity in liters and percentual (FVC; %FVC )

Other

MeasureTime frameDescription
Respiratory Muscle StrengthPatients were followed for five daysMaximum inspiratory pressure (MIP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026