Using positive pressure therapy to improve lung function after heart surgery

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

This study is testing two types of breathing treatments to see which one helps heart surgery patients recover better and avoid lung problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Federal University of São Paulo (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06611527 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of two positive pressure therapies, Continuous Positive Airway Pressure (CPAP) and Positive Pressure Support with Positive End-Expiratory Pressure (PS+PEEP), in reducing pulmonary complications in patients recovering from myocardial revascularization and valve surgeries. The study focuses on patients who are at risk of developing respiratory issues post-surgery, particularly those with mild to moderate pulmonary dysfunction. By assessing the incidence of complications, the trial seeks to determine which therapy is more beneficial in the immediate postoperative period.

Who should consider this trial

Good fit: Ideal candidates include patients in the immediate postoperative period of heart surgery who have risk factors for pulmonary complications.

Not a fit: Patients with hemodynamic instability or severe acute arrhythmias may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of pulmonary complications in patients recovering from heart surgery.

How similar studies have performed: Previous studies have shown positive outcomes with similar positive pressure therapies in postoperative care, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Instituto do Coração - HCFMUSP — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Marcia S Volpe, PhD — Federal University of São Paulo
• Study coordinator: Marcia S Volpe, PhD

Conditions Postoperative Period; Physical Therapy Modalities; Continuous Positive Airway Pressure; Respiratory Function Tests; Pulmonary Atelectasis; Heart Surgery