Actively Recruiting
Comparison Between Two Methods of Positive Pressure Therapy in the Prevention of Pulmonary Complications in the Immediate Postoperative Period of Cardiac Surgery: a Prospective, Randomized Clinical Trial
Led by Federal University of São Paulo · Updated on 2025-04-10
156
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating two types of positive pressure therapies, continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP), to reduce lung complications after heart surgeries such as myocardial revascularization and valve replacement or plastic surgery. These lung complications are common after cardiac surgery and can increase hospital stays and risks to health. The study aims to find out if PS+PEEP and CPAP have similar effects in improving lung function in patients with mild to moderate lung problems immediately after surgery. Participants will be randomly assigned to one of two groups during the immediate postoperative period. One group will receive PS+PEEP therapy involving four sets of 20 breaths with pressure settings tailored to body weight and oxygen levels. The other group will receive CPAP therapy set at a constant pressure for 30 minutes to maintain oxygen saturation. Both therapies aim to support lung expansion and oxygen levels to help recovery. During the study, participants will undergo lung function tests including spirometry, respiratory muscle strength, handgrip strength, and electrical impedance tomography to monitor lung ventilation during and after therapy. Researchers will follow participants for seven days after surgery to assess lung complications. Additional assessments include length of ICU and hospital stay, comfort with therapy, and muscle strength on days 5 and 7 post-surgery. This comprehensive monitoring helps evaluate how the therapies affect recovery and lung health over time.
CONDITIONS
Brief 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
- Preoperative patients at risk of pulmonary complications with at least 2 risk factors: age 70 years or older, productive cough, diabetes, smoking history, COPD with FEV1 below 75% predicted, BMI 27 kg/m2 or higher, or FEV1 below 80% and FEV1/FVC ratio below 70%
- Postoperative patients (up to 12 hours after extubation) with mild to moderate pulmonary complications defined by 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 of any cause
- Need for intra-aortic balloon
- Invasive mechanical ventilation longer than 24 hours after surgery
- Pulmonary complication score grade 3 or higher
- Signs of acute respiratory failure such as respiratory rate 25 breaths/min or higher and use of accessory muscles
- Chest tube with air leak
- Use of pacemaker or implantable or external cardioverter-defibrillator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 hours after extubation
Participants undergo cardiac surgery followed by immediate postoperative care including application of positive pressure therapy using one of two methods.
Therapy sessions include 4 sets of 20 repetitions or 30 minutes of continuous application
Duration - 7 days after surgery
Participants are monitored for pulmonary complications and assessed for lung function and strength during the first week after surgery.
Assessments on preoperative day, and postoperative days 5 and 7; monitoring during and 30 minutes after therapy sessions
Duration - Up to 28 days after surgery
Participants are observed for length of ICU and hospital stay up to 28 days after surgery.
Daily observation until ICU and hospital discharge
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
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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