Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

NCT06611527 | Recruiting

• 1 other identifier: RPPI
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Severity of pulmonary complications in the postoperative period

  Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one (5) means death before hospital discharge, and degree 4 means need of invasive mechanical ventilation due to acute respiratory failure.

  Participants will be followed for 7 days after surgery.

• Electrical impedance tomography (EIT) ventilation distribution

  EIT ventilation distribution will be monitored during and 30 minutes after the therapies.

Secondary Outcomes (6)

• Length of ICU stay

  From the day of surgery up to ICU discharge, an expected average of 2 days, and maximum censoring at day 28 after surgery.

• Length of hospital stay

  From the day of surgery up to hospital discharge, an expected average of 10 days, and maximum censoring at day 28 after surgery.

• Handgrip strength

  Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.

• Maximal inspiratory and expiratory pressures

  Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.

• Spirometry test results

  Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.

Study Arms (2)

PS+PEEP group

ACTIVE COMPARATOR

PS+PEEP modality involves the application of two levels of positive pressure intermittently.

Device: PS+PEEP group

CPAP group

EXPERIMENTAL

Continuous positive airway pressure modality.

Device: CPAP group

Interventions

PS+PEEP group DEVICE

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%

PS+PEEP group

CPAP group DEVICE

Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

CPAP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• InCor Heart Institute: collaborator

Study Sites (1)

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcia S Volpe, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia S Volpe, PhD

CONTACT

+551133854255; marcia.volpe@unifesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be avaible from 12 months to 36 months after publication.

Locations

BR (1)