Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04023643 |
Other study ID # |
90326618.7.1001.0076 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
May 2022 |
Source |
São Paulo State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 children, emphasizing the duration of the process.
There are no similar studies in the world.
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.