Search / Trial NCT06611527

Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

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

Trial Information

Current as of December 30, 2024

Not yet recruiting

Keywords

ClinConnect Summary

No description provided

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.

Trial Officials

Marcia S Volpe, PhD

Principal Investigator

Federal University of São Paulo

About Federal University Of São Paulo

The Federal University of São Paulo (Universidade Federal de São Paulo - UNIFESP) is a prestigious institution dedicated to advancing education, research, and healthcare in Brazil. Renowned for its commitment to innovation and excellence, UNIFESP plays a pivotal role in clinical research, focusing on a multidisciplinary approach to improve health outcomes. The university fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that clinical trials conducted under its auspices adhere to rigorous ethical standards and contribute valuable insights to the medical field. With a rich history of academic achievement and a strong emphasis on translational research, UNIFESP is a key player in the development of new therapies and medical interventions.

Locations

Santos, Sp, Brazil

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0