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Completed

NCT Number: NCT02278835

The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing exercises

Other

3 sets of 10 repetitions of deep breathing exercises

Other names: EXE

Incentive spirometry

Device

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

Other names: IS (Coach®)

Intermittent positive pressure breathing

Device

20 minutes breathing with intermittent positive pressure

Other names: IPPB (BIRD Mark 7™)

Continuous Positive Airway Pressure

Device

20 minutes breathing with continuous positive airway pressure

Other names: CPAP (Sullivan®)

Primary outcomes

  1. incidence of atelectasis

    Time frame: Patients were followed for five days

Secondary outcomes

  1. pulmonary function

    Time frame: Patients were followed for five days

    Forced vital capacity in liters and percentual (FVC; %FVC )

  2. pulmonary function

    Time frame: Patients were followed for five days

    Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)

  3. pulmonary function

    Time frame: Patients were followed for five days

    Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)

Other outcomes

  1. Respiratory Muscle Strength

    Time frame: Patients were followed for five days

    Maximum inspiratory pressure (MIP)

  2. Respiratory Muscle Strength

    Time frame: Patients were followed for five days

    Maximum expiratory pressure (MEP)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2014
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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