Postoperative PeriodPRO-LUNGHSNCT06611527
Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
A study testing PS+PEEP group and CPAP group in people with Postoperative Period and Physical Therapy Modalities, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Period, Physical Therapy Modalities, Continuous Positive Airway Pressure
- What is being tested?
- PS+PEEP group and CPAP group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403-900
Marcia Volpe, Doctor, 55-11-933396164, marcia.volpe@unifesp.br
About this study
Official title: 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.
Read more
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
- Being tested
- PS+PEEP group, CPAP group
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS+PEEP groupDevice
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%
CPAP groupDevice
Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PS+PEEP group | Active comparator | PS+PEEP modality involves the application of two levels of positive pressure intermittently. Receives: Device: PS+PEEP group |
| CPAP group | Experimental | Continuous positive airway pressure modality. Receives: Device: CPAP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for 7 days after surgery.
Electrical impedance tomography (EIT) ventilation distribution
Measured: EIT ventilation distribution will be monitored during and 30 minutes after the therapies.
Secondary outcomes (6)
Length of ICU stay
Measured: 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
Measured: 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
Measured: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
Maximal inspiratory and expiratory pressures
Measured: 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.
Measured: 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.
Measured: The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start8 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Principal investigator, Marcia Souza Volpe, Federal University of São Paulo
- Investigators
- Marcia S Volpe, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611527
- Sponsor's protocol ID
- RPPI
- Acronym
- PRO-LUNGHS
- Status last verified
- Apr 2025
- First submitted
- 18 Sep 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be stored at https://domusdados.unifesp.br/ All IPD that results in a publication will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06611527
- Acronym / sponsor ID
- PRO-LUNGHS / RPPI
- Conditions
- Postoperative Period, Physical Therapy Modalities, Continuous Positive Airway Pressure, Respiratory Function Tests, Pulmonary Atelectasis, Heart Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS+PEEP group | Active comparator | Device: PS+PEEP groupPS+PEEP modality involves the application of two levels of positive pressure intermittently. |
| CPAP group | Experimental | Device: CPAP groupContinuous positive airway pressure modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS+PEEP groupApplication 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% | Device | PS+PEEP group |
| CPAP groupApplication of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes. | Device | CPAP group |
Primary outcome
Severity of pulmonary complications in the postoperative period
Time frame: Participants will be followed for 7 days after surgery.
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.
Electrical impedance tomography (EIT) ventilation distribution
Time frame: EIT ventilation distribution will be monitored during and 30 minutes after the therapies.
6 secondary outcomes
Length of ICU stay
Time frame: 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
Time frame: 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
Time frame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
Maximal inspiratory and expiratory pressures
Time frame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
Spirometry test results
Time frame: Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.
Positive pressure therapy comfort level
Time frame: The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Yes. IPD will be stored at https://domusdados.unifesp.br/ All IPD that results in a publication will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcia S Volpe, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS+PEEP group and CPAP group in people with Postoperative Period and Physical Therapy Modalities, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcia S Volpe, PhD (+551133854255, marcia.volpe@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pulmonary complications in the postoperative period (time frame: Participants will be followed for 7 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.