Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of breathing therapies, Continuous Positive Airway Pressure (CPAP) and Positive Pressure Support with Positive End-Expiratory Pressure (PS+PEEP), to see which one helps patients recover better after heart surgery. Heart surgeries, like valve replacements or myocardial revascularization, can lead to lung problems in 30% to 50% of patients, making recovery more difficult. The trial aims to find out if patients with mild to moderate lung issues after surgery have similar improvements in their lung function when treated with either CPAP or PS+PEEP.

To be eligible for the trial, participants need to be in the immediate recovery period after heart surgery and have certain risk factors for lung complications, such as being over 70 years old, having a history of smoking, or having chronic lung conditions. Participants will be randomly assigned to one of the two treatment groups and will undergo tests to measure how well their lungs are working. The trial is currently recruiting patients, and it’s important to know that those with specific heart or lung issues may not be eligible to participate.

Gender

ALL

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.