Status:
RECRUITING
Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Postoperative Period
Physical Therapy Modalities
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06611527
Start Date
January 8 2025
End Date
December 1 2027
Last Update
April 10 2025
Active Locations (1)
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1
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil, 05403-900