Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery (PRO-LUNGHS)

Comparison Between Two Methods of Positive Pressure Therapy in the Prevention of Pulmonary Complications in the Immediate Postoperative Period of Cardiac Surgery: a Prospective, Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Atelectasis; Heart Surgery; Continuous Positive Airway Pressure; Physical Therapy Modalities; Postoperative Period; Respiratory Function Tests
• Intervention / Treatment: Device: PS+PEEP group; Device: CPAP group

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcia S Volpe, PhD; Phone Number: +551133854255; Email: marcia.volpe@unifesp.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-900
      • Recruiting
      • Instituto do Coracao - HCFMUSP
      • Contact: Marcia Volpe, Doctor; Phone Number: 55-11-933396164; Email: marcia.volpe@unifesp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PS+PEEP group; PS+PEEP modality involves the application of two levels of positive pressure intermittently.	Device: PS+PEEP group; 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: CPAP group; Continuous positive airway pressure modality.	Device: CPAP group; Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio from the spirometry test will be presented as percentages of predicted values.	Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.
Positive pressure therapy comfort level	Comfort during positive pressure therapy will be assessed using a visual analog scale ranging from 0 to 10, where 0 represents maximum comfort and 10 represents extreme discomfort.	The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: InCor Heart Institute
• Investigators: Principal Investigator: Marcia S Volpe, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: RPPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be stored at https://domusdados.unifesp.br/ All IPD that results in a publication will be shared upon reasonable request.
• IPD Sharing Time Frame: IPD will be avaible from 12 months to 36 months after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No