Respiration, ArtificialPROVENTUSNCT04023643
Pediatric Ventilation Weaning
A study testing Ventilation Weaning in people with Respiration, Artificial and Ventilator Weaning, run by São Paulo State University at 5 sites in Brazil.
Trial summary
The hypothesis of the present study is that the use of Continuous Positive Airway Pressure (CPAP) plus PS can accelerate the weaning process and, consequently, shorten the MV. This multicenter, pragmatic clinical trial aims to compare the use of CPAP + PS versus SIMV + PS as a method for ventilatory weaning of… Read more about this study
- Who is it for?
- Ages 29 days to 15 years
- Conditions the study is for
- Respiration, Artificial, Ventilator Weaning
- What is being tested?
- Ventilation Weaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesBrazil
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who underwent mechanical ventilation for at least 24 hours in one of the participant PICUs
Who cannot join
- Children dependent on mechanical ventilation and / or chronically supplemental oxygen;
- Children with do not resuscitation order (DNR)
- Children with neurological and neuromuscular disorders that may interfere with MV;
- Children with chronic lung diseases (such as cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, with the exception of asthma);
- Children transferred from another PICU not included in the trial and whose weaning has already begun;
- Children whose cannulae have air leakage higher of 25% of inspiratory flow, without indication for cannula replacement.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Hospital das Clínicas de Marília - Unidade II
Marília, São Paulo, 17500030
Hospital Municipal Vila Santa Catarina
São Paulo, 04378-500
Hospital Municipal Dr. Moysés Deutsch
São Paulo, 04948-970
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
Hospital Universitário da Universidade de São Paulo
São Paulo, 05508-000
About this study
Official title: Pragmatic And Randomized Pediatric Ventilation Weaning Trial
The hypothesis of the present study is that the use of Continuous Positive Airway Pressure (CPAP) plus PS can accelerate the weaning process and, consequently, shorten the MV. This multicenter, pragmatic clinical trial aims to compare the use of CPAP + PS versus SIMV + PS as a method for ventilatory weaning of children, emphasizing the duration of the process. There are no similar studies in the world.
Read the detailed description
Mechanical ventilation (MV) is a widely used practice among Pediatric Intensive Care Units (PICUs) throughout the world. Data from multicenter studies reveal rates ranging from 20% to 64% use, lasting about 5 to 6 days.
The practice of using artificial methods to provide respiratory care is considered a revolution in the care of critically ill patients, reducing their morbidity and mortality. On the other hand, it is widely known that these tools bring with it a myriad of possible complications, such as Health Care-Associated Pneumonia, upper and lower airway injuries, risks related to sedation, and cardiovascular instability. Therefore, it is indispensable to interrupt the MV as soon as possible.
When is spent a lot of time recognizing that the MV is no longer essential, is increased the risks and costs (up to $ 2,000 a day), and is failed the good medical practice. Currently, the duration of weaning consumes about 40% of the total MV time. This depends on many factors, such as fluid balance, positive end expiratory pressure (PEEP), sedation, pulmonary hypertension and diaphragm function, among others.
Studies have shown that the implementation of a weaning protocol reduces its duration and, consequently, ventilation in children. There are numerous known weaning techniques, however, the most commonly used approach is the progressive reduction of ventilatory support already in use, maintaining the same modes and reducing the parameters. Some professionals choose synchronized intermittent mandatory ventilation (SIMV), reducing respiratory rate, with or without Supplementary Pressure (PS) association. Others prefer to perform daily extubation readiness tests (ERT) or to switch spontaneous breathing methods with full-support ventilation for respiratory muscle training, this practice is more common in adult ICUs. Exhorted by recommendations for mechanical ventilation of critically ill children at the 2017 pediatric mechanical ventilation consensus conference (PEMVECC), who concluded with strong agreement that there is insufficient data to recommend the method for weaning the investigators decided to study the assertive.
- Conditions
- Respiration, Artificial, Ventilator Weaning
- Being tested
- Ventilation Weaning
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation WeaningOther
Use of different weaning strategies
| Study group | Role | What they receive |
|---|---|---|
| CPAP + PS | Experimental | Weaning from mechanical ventilation using CPAP + PS Receives: Other: Ventilation Weaning |
| SIMV + PS | Active comparator | Weaning from mechanical ventilation using SIMV+PS Receives: Other: Ventilation Weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Ventilator-free days
Rate of free days of mechanical ventilation during ICU admission in children who were intubated. Assessed by the data collection form filled daily by the collaborators.
Measured: 4 days
Rate of Weaning duration
Amount of hours spent in ventilator weaning. Assessed by the data collection form filled daily by the collaborators.
Measured: 12 hours
Secondary outcomes (3)
Rate of PICU length of Stay
Amount of days spent in PICU. Assessed by the data collection form filled daily by the collaborators.
Measured: 10 days
Incidence of Complications associated with mechanical ventilation
Incidence of Health Care associated Pneumonia; tracheitis; barotrauma; extubation laryngitis. Diagnosed according to the protocols in force at the institution and Assessed by the data collection form filled daily by the collaborators.
Measured: 10 days
Rates of spontaneous breathing test failure
Rates of spontaneous breathing test failure. Assessed by the data collection form filled daily by the collaborators.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2020
- Primary completion20 May 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- Andréa Maria Cordeiro Ventura
- Responsible party
- Principal investigator, Murilo Lourenção, São Paulo State University
- Investigators
- Murilo Lourenção, MD, Principal investigator, HU-USPAndrea Ventura, MSC, MD, Study director, HU-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023643
- Sponsor's protocol ID
- 90326618.7.1001.0076
- Acronym
- PROVENTUS
- Status last verified
- May 2022
- First submitted
- 12 Jul 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic And Randomized Pediatric Ventilation Weaning Trial
- ClinicalTrials.gov ID
- NCT04023643
- Acronym / sponsor ID
- PROVENTUS / 90326618.7.1001.0076
- Conditions
- Respiration, Artificial, Ventilator Weaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- Andréa Maria Cordeiro Ventura
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Jul 2019 (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 hypothesis of the present study is that the use of Continuous Positive Airway Pressure (CPAP) plus PS can accelerate the weaning process and, consequently, shorten the MV. This multicenter, pragmatic clinical trial aims to compare the use of CPAP + PS versus SIMV + PS as a method for ventilatory weaning of children, emphasizing the duration of the process. There are no similar studies in the world.
Detailed description
Mechanical ventilation (MV) is a widely used practice among Pediatric Intensive Care Units (PICUs) throughout the world. Data from multicenter studies reveal rates ranging from 20% to 64% use, lasting about 5 to 6 days.
The practice of using artificial methods to provide respiratory care is considered a revolution in the care of critically ill patients, reducing their morbidity and mortality. On the other hand, it is widely known that these tools bring with it a myriad of possible complications, such as Health Care-Associated Pneumonia, upper and lower airway injuries, risks related to sedation, and cardiovascular instability. Therefore, it is indispensable to interrupt the MV as soon as possible.
When is spent a lot of time recognizing that the MV is no longer essential, is increased the risks and costs (up to $ 2,000 a day), and is failed the good medical practice. Currently, the duration of weaning consumes about 40% of the total MV time. This depends on many factors, such as fluid balance, positive end expiratory pressure (PEEP), sedation, pulmonary hypertension and diaphragm function, among others.
Studies have shown that the implementation of a weaning protocol reduces its duration and, consequently, ventilation in children. There are numerous known weaning techniques, however, the most commonly used approach is the progressive reduction of ventilatory support already in use, maintaining the same modes and reducing the parameters. Some professionals choose synchronized intermittent mandatory ventilation (SIMV), reducing respiratory rate, with or without Supplementary Pressure (PS) association. Others prefer to perform daily extubation readiness tests (ERT) or to switch spontaneous breathing methods with full-support ventilation for respiratory muscle training, this practice is more common in adult ICUs. Exhorted by recommendations for mechanical ventilation of critically ill children at the 2017 pediatric mechanical ventilation consensus conference (PEMVECC), who concluded with strong agreement that there is insufficient data to recommend the method for weaning the investigators decided to study the assertive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP + PS | Experimental | Other: Ventilation WeaningWeaning from mechanical ventilation using CPAP + PS |
| SIMV + PS | Active comparator | Other: Ventilation WeaningWeaning from mechanical ventilation using SIMV+PS |
Who may qualify
- Ages
- 29 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who underwent mechanical ventilation for at least 24 hours in one of the participant PICUs
Key exclusion criteria (6 listed)
- Children dependent on mechanical ventilation and / or chronically supplemental oxygen;
- Children with do not resuscitation order (DNR)
- Children with neurological and neuromuscular disorders that may interfere with MV;
- Children with chronic lung diseases (such as cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, with the exception of asthma);
- Children transferred from another PICU not included in the trial and whose weaning has already begun;
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 |
|---|---|---|
| Ventilation WeaningUse of different weaning strategies | Other | CPAP + PS, SIMV + PS |
Primary outcome
Rate of Ventilator-free days
Time frame: 4 days
Rate of free days of mechanical ventilation during ICU admission in children who were intubated. Assessed by the data collection form filled daily by the collaborators.
Rate of Weaning duration
Time frame: 12 hours
Amount of hours spent in ventilator weaning. Assessed by the data collection form filled daily by the collaborators.
3 secondary outcomes
Rate of PICU length of Stay
Time frame: 10 days
Incidence of Complications associated with mechanical ventilation
Time frame: 10 days
Rates of spontaneous breathing test failure
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Murilo Lourenção, MD principal investigator
HU-USP
Andrea Ventura, MSC, MD study director
HU-USP
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation Weaning in people with Respiration, Artificial and Ventilator Weaning, run by São Paulo State University at 5 sites 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Ventilator-free days (time frame: 4 days). 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 23 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.