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Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

RecruitingNAAges 18 Years - anyAllFederal University of São Paulo
NCT06611527 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery. In the postoperative period of cardiac surgeries, the incidence of pulmonary complications ranges from 30% to 50% and is associated with increased length of hospital stay and morbidity and mortality. To reduce or minimize the occurrence of these complications, respiratory physiotherapy employs positive pressure reexpansion therapies, such as continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP). The goal of this clinical trial is to compare the effects of two positive pressure therapies, CPAP versus PS+PEEP, on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery, with mild to moderate pulmonary dysfunction. The m

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📋 Eligibility rules (as published)
Inclusion Criteria: * Immediate postoperative period of myocardial revascularization and/or valve replacement or plastic surgery; * Patients in the preoperative period at risk of developing pulmonary complications, characterized by the presence of at least 2 of the following risk factors: age ≥ 70 years, productive cough, diabetes, history of smoking, chronic obstructive pulmonary disease (COPD) defined by forced expiratory volume in 1 second (FEV1) lower than 75% of predicted, body mass index (BMI) ≥ 27 kg/m2, or only FEV1 lower than 80% and FEV1/forced vital capacity (FVC) ratio lower than 70% of predicted; OR patients in the postoperative period (up to 12 hours after extubation) with mild to moderate complications characterized by a pulmonary complication score lower than 3. Exclusion Criteria: * Hemodynamic instability characterized by mean arterial pressure (MAP) lower than 60mmHg and/or acute arrhythmia of any etiology; * Need for intra-aortic balloon; * Duration of invasive mechanical ventilation exceeding 24 hours after surgery; * Pulmonary complication score ≥ grade 3; * Presence of signs of acute respiratory failure, such as respiratory rate (f) ≥ 25 breaths/min and use of accessory muscles; * Chest tube with air leak; * Use of a pacemaker or implantable or external cardioverter-defibrillator.
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What it tests

  • PS+PEEP group
  • CPAP group
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Where

1 site
Instituto do Coração - HCFMUSP
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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