Pediatric Ventilation Weaning

Respiration, Artificial Clinical Trial

— PROVENTUS  

Official title:

Pragmatic And Randomized Pediatric Ventilation Weaning Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04023643
• Other study ID #: 90326618.7.1001.0076
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiration, Artificial
• Ventilator Weaning

Intervention

Other:
• Ventilation Weaning
Use of different weaning strategies

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Marília - Unidade II	Marília	SP
Brazil	Hospital Municipal Dr. Moysés Deutsch	São Paulo
Brazil	Hospital Municipal Vila Santa Catarina	São Paulo
Brazil	Hospital Universitário da Universidade de São Paulo	São Paulo
Brazil	Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
São Paulo State University	Andréa Maria Cordeiro Ventura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 days
Primary	Rate of Weaning duration	Amount of hours spent in ventilator weaning. Assessed by the data collection form filled daily by the collaborators.	12 hours
Secondary	Rate of PICU length of Stay	Amount of days spent in PICU. Assessed by the data collection form filled daily by the collaborators.	10 days
Secondary	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.	10 days
Secondary	Rates of spontaneous breathing test failure	Rates of spontaneous breathing test failure. Assessed by the data collection form filled daily by the collaborators.	6 days