Pediatric Ventilation Weaning

NCT04023643 | Unknown

• 1 other identifier: 90326618.7.1001.0076
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Respiration, Artificial; Ventilator Weaning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

CPAP + PS

EXPERIMENTAL

Weaning from mechanical ventilation using CPAP + PS

Other: Ventilation Weaning

SIMV + PS

ACTIVE COMPARATOR

Weaning from mechanical ventilation using SIMV+PS

Other: Ventilation Weaning

Interventions

Ventilation Weaning OTHER

Use of different weaning strategies

CPAP + PS; SIMV + PS

Eligibility Criteria

• Age: 29 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who underwent mechanical ventilation for at least 24 hours in one of the participant PICUs

You may not qualify if:

• 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.

Sponsors & Collaborators

• São Paulo State University: lead
• Andréa Maria Cordeiro Ventura: collaborator

Study Sites (5)

Hospital das Clínicas de Marília - Unidade II

Marília, São Paulo, 17500030, Brazil

Location

Hospital Municipal Vila Santa Catarina

São Paulo, 04378-500, Brazil

Location

Hospital Municipal Dr. Moysés Deutsch

São Paulo, 04948-970, Brazil

Location

Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

Hospital Universitário da Universidade de São Paulo

São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murilo Lourenção, MD

  HU-USP

  PRINCIPAL INVESTIGATOR

• Andrea Ventura, MSC, MD

  HU-USP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: October 1, 2020
• Primary Completion: May 20, 2022
• Study Completion: December 31, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BR (5)