| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiration, Artificial Ventilator Weaning | Other: Ventilation Weaning | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pragmatic And Randomized Pediatric Ventilation Weaning Trial |
| Actual Study Start Date : | October 1, 2020 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: CPAP + PS
Weaning from mechanical ventilation using CPAP + PS
|
Other: Ventilation Weaning
Use of different weaning strategies
|
|
Active Comparator: SIMV + PS
Weaning from mechanical ventilation using SIMV+PS
|
Other: Ventilation Weaning
Use of different weaning strategies
|
| Ages Eligible for Study: | up to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Murilo Lourenção, MD | +5511947100733 | murilo.ll@hotmail.com |
| Brazil | |
| Hospital das Clínicas de Marília - Unidade II | Recruiting |
| Marília, SP, Brazil, 17500030 | |
| Contact: Fernanda Augusto, MD PhD | |
| Hospital Municipal Vila Santa Catarina | Recruiting |
| São Paulo, Brazil, 04378-500 | |
| Contact: Albert Bousso, PhD, MSC, MD | |
| Principal Investigator: Tadeu Renattini | |
| Hospital Municipal Dr. Moysés Deutsch | Recruiting |
| São Paulo, Brazil, 04948-970 | |
| Contact: Fernanda Elias, MD | |
| Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| São Paulo, Brazil, 05403-000 | |
| Contact: Arthur Delgado, PhD, MSC, MD | |
| Hospital Universitário da Universidade de São Paulo | Recruiting |
| São Paulo, Brazil, 05508-000 | |
| Contact: Andrea Ventura, MSC, MD | |
| Principal Investigator: | Murilo Lourenção, MD | HU-USP | |
| Study Director: | Andrea Ventura, MSC, MD | HU-USP |
| Tracking Information | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 12, 2019 | ||||||||||
| First Posted Date ICMJE | July 17, 2019 | ||||||||||
| Last Update Posted Date | October 27, 2020 | ||||||||||
| Actual Study Start Date ICMJE | October 1, 2020 | ||||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
| Descriptive Information | |||||||||||
| Brief Title ICMJE | Pediatric Ventilation Weaning | ||||||||||
| Official Title ICMJE | Pragmatic And Randomized Pediatric Ventilation Weaning Trial | ||||||||||
| 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. |
||||||||||
| Study Type ICMJE | Interventional | ||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||||
| Condition ICMJE |
|
||||||||||
| Intervention ICMJE | Other: Ventilation Weaning
Use of different weaning strategies
|
||||||||||
| Study Arms ICMJE |
|
||||||||||
| Publications * | Not Provided | ||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||
| Recruitment Information | |||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||
| Sex/Gender ICMJE |
|
||||||||||
| Ages ICMJE | up to 15 Years (Child) | ||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||
| Contacts ICMJE |
|
||||||||||
| Listed Location Countries ICMJE | Brazil | ||||||||||
| Removed Location Countries | |||||||||||
| Administrative Information | |||||||||||
| NCT Number ICMJE | NCT04023643 | ||||||||||
| Other Study ID Numbers ICMJE | 90326618.7.1001.0076 | ||||||||||
| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
||||||||||
| Responsible Party | Murilo Lourenção, São Paulo State University | ||||||||||
| Study Sponsor ICMJE | São Paulo State University | ||||||||||
| Collaborators ICMJE | Andréa Maria Cordeiro Ventura | ||||||||||
| Investigators ICMJE |
|
||||||||||
| PRS Account | São Paulo State University | ||||||||||
| Verification Date | October 2020 | ||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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