Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06611527

Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

Led by Federal University of São Paulo · Updated on 2025-04-10

156

Participants Needed

1

Research Sites

151 weeks

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

The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery. In the postoperative period of cardiac surgeries, the incidence of pulmonary complications ranges from 30% to 50% and is associated with increased length of hospital stay and morbidity and mortality. To reduce or minimize the occurrence of these complications, respiratory physiotherapy employs positive pressure reexpansion therapies, such as continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP). The goal of this clinical trial is to compare the effects of two positive pressure therapies, CPAP versus PS+PEEP, on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery, with mild to moderate pulmonary dysfunction. The main question it aims to answer is: Do patients in the immediate postoperative period of myocardial revascularization or valve replacement/plastic surgery, exhibiting mild to moderate pulmonary dysfunction, experience a comparable reversal of pulmonary conditions when treated with PS+PEEP versus CPAP? Participants will undergo the following assessments: spirometry, respiratory muscle strength testing, handgrip strength testing, and electrical impedance tomography. In the immediate postoperative period, participants will be randomized into two treatment groups: • Control Group PS+PEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%; • Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

CONDITIONS

Official Title

Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Immediate postoperative period of myocardial revascularization and/or valve replacement or plastic surgery
  • At risk of pulmonary complications before surgery, shown by at least 2 of these: age 70 or older, productive cough, diabetes, smoking history, COPD with FEV1 less than 75% predicted, BMI 27 kg/m2 or higher, or FEV1 less than 80% and FEV1/FVC ratio less than 70% predicted
  • Or patients within 12 hours after extubation in the postoperative period with mild to moderate pulmonary complications and a pulmonary complication score less than 3
Not Eligible

You will not qualify if you...

  • Hemodynamic instability with mean arterial pressure below 60 mmHg or acute arrhythmia
  • Need for intra-aortic balloon
  • Invasive mechanical ventilation lasting longer than 24 hours after surgery
  • Pulmonary complication score of grade 3 or higher
  • Signs of acute respiratory failure, including respiratory rate 25 breaths/min or more and use of accessory muscles
  • Chest tube with air leak
  • Use of pacemaker or implantable/external cardioverter-defibrillator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, Brazil, 05403-900

Actively Recruiting

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Research Team

M

Marcia S Volpe, PhD

CONTACT

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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