Using positive pressure therapy to improve lung function after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: marcia.volpe@unifesp.br
• Phone: +551133854255

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.