Pediatric Ventilation Weaning (PROVENTUS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiration, Artificial; Ventilator Weaning
• Intervention / Treatment: Other: Ventilation Weaning

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: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04378-500
    • Hospital Municipal Vila Santa Catarina
  • São Paulo, Brazil, 05508-000
    • Hospital Universitário da Universidade de Sao Paulo
  • São Paulo, Brazil, 04948-970
    • Hospital Municipal Dr. Moysés Deutsch
  • São Paulo, Brazil, 05403-000
    • Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • SP
    • Marília, SP, Brazil, 17500030
      • Hospital das Clínicas de Marília - Unidade II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: São Paulo State University
• Collaborators: Andréa Maria Cordeiro Ventura
• Investigators: Principal Investigator: Murilo Lourenção, MD, HU-USP; Study Director: Andrea Ventura, MSC, MD, HU-USP

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 20, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 90326618.7.1001.0076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No