Pragmatic And Randomized Pediatric Ventilation Weaning Trial
Pediatric Ventilation Weaning
Sponsors
Source
São Paulo State University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief 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 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.
Overall Status
Not yet recruiting
Start Date
2020-01-01
Completion Date
2021-12-31
Primary Completion Date
2021-06-30
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Rate of Ventilator-free days |
4 days |
|
Rate of Weaning duration |
12 hours |
Secondary Outcome
Measure |
Time Frame |
|
Rate of PICU length of Stay |
10 days |
|
Incidence of Complications associated with mechanical ventilation |
10 days |
|
Rates of spontaneous breathing test failure |
6 days |
Enrollment
300
Conditions
Intervention
Intervention Type
Other
Intervention Name
Description
Use of different weaning strategies
Arm Group Label
CPAP + PS
SIMV + PS
Eligibility
Criteria
Inclusion Criteria:
- Children who underwent mechanical ventilation for at least 24 hours in one of the
participant PICUs
Exclusion Criteria:
- 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.
Gender
All
Minimum Age
N/A
Maximum Age
15 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Murilo Lourenção, MD |
Principal Investigator |
HU-USP |
|
Andrea Ventura, MSC, MD |
Study Director |
HU-USP |
Overall Contact
Location
Facility |
Status |
Contact |
|
Hospital Municipal Vila Santa Catarina São Paulo 04378-500 Brazil |
Not yet recruiting |
Last Name: Albert Bousso, PhD, MSC, MD |
|
Hospital Municipal Dr. Moysés Deutsch São Paulo 04948-970 Brazil |
Not yet recruiting |
Last Name: Daniela Medeiros, MD |
|
Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo 05403-000 Brazil |
Not yet recruiting |
Last Name: Arthur Delgado, PhD, MSC, MD |
|
Hospital Universitário da Universidade de São Paulo São Paulo 05508-000 Brazil |
Not yet recruiting |
Last Name: Andrea Ventura, MSC, MD |
Location Countries
Country
Brazil
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
São Paulo State University
Investigator Full Name
Murilo Lourenção
Investigator Title
Principal investigator
Has Expanded Access
No
Number Of Arms
2
Arm Group
Arm Group Label
CPAP + PS
Arm Group Type
Experimental
Description
Weaning from mechanical ventilation using CPAP + PS
Arm Group Label
SIMV + PS
Arm Group Type
Active Comparator
Description
Weaning from mechanical ventilation using SIMV+PS
Firstreceived Results Date
N/A
Acronym
PROVENTUS
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)
Study First Submitted
July 12, 2019
Study First Submitted Qc
July 16, 2019
Study First Posted
July 17, 2019
Last Update Submitted
July 16, 2019
Last Update Submitted Qc
July 16, 2019
Last Update Posted
July 17, 2019
ClinicalTrials.gov processed this data on July 17, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.