Actively Recruiting
Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
Led by Federal University of São Paulo · Updated on 2025-04-10
156
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
F
Federal University of São Paulo
Lead Sponsor
I
InCor Heart Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 main question it aims to answer is: Do patients in the immediate postoperative period of myocardial revascularization or valve replacement/plastic surgery, exhibiting mild to moderate pulmonary dysfunction, experience a comparable reversal of pulmonary conditions when treated with PS+PEEP versus CPAP? Participants will undergo the following assessments: spirometry, respiratory muscle strength testing, handgrip strength testing, and electrical impedance tomography. In the immediate postoperative period, participants will be randomized into two treatment groups: • Control Group PS+PEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%; • Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.
CONDITIONS
Official Title
Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Immediate postoperative period of myocardial revascularization and/or valve replacement or plastic surgery
- At risk of pulmonary complications before surgery, shown by at least 2 of these: age 70 or older, productive cough, diabetes, smoking history, COPD with FEV1 less than 75% predicted, BMI 27 kg/m2 or higher, or FEV1 less than 80% and FEV1/FVC ratio less than 70% predicted
- Or patients within 12 hours after extubation in the postoperative period with mild to moderate pulmonary complications and a pulmonary complication score less than 3
You will not qualify if you...
- Hemodynamic instability with mean arterial pressure below 60 mmHg or acute arrhythmia
- Need for intra-aortic balloon
- Invasive mechanical ventilation lasting longer than 24 hours after surgery
- Pulmonary complication score of grade 3 or higher
- Signs of acute respiratory failure, including respiratory rate 25 breaths/min or more and use of accessory muscles
- Chest tube with air leak
- Use of pacemaker or implantable/external cardioverter-defibrillator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil, 05403-900
Actively Recruiting
Research Team
M
Marcia S Volpe, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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