Completed

The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Pathologic Processes+2

+ Respiration Disorders

+ Respiratory Tract Diseases

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2019
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Summary

Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 26, 2019

Actual date on which the first participant was enrolled.

Early and successful Extubation is sometimes a difficult combination in children, since the criteria for suggesting it are often subjective and poorly defined. Electrical impedance tomography (EIT) has been developed and used clinically for more than 30 years. Interest in this technology arose from the need to monitor ventilation and pulmonary perfusion at the bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in the pediatric population. Objectives: To correlate the data obtained by the EIT during the spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation failure and to observe if the EIT is able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be described using absolute and relative frequencies and the quantitative characteristics will be described using summary measures (mean, standard deviation, median, minimum and maximum). Bivariate and later multiple logistic regression analyzes will be performed to evaluate the influence of characteristics assessed on weaning failure, mainly the reduction in functional residual capacity during and after the weaning trial. For the analysis will be used the software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft Excel 2010 software. The tests will be performed with significance level of 5%.

Official TitleThe Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
NCT04011852
Principal SponsorUniversity of Sao Paulo General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

83 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesRespiration DisordersRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsRespiratory Aspiration

Criteria

Inclusion Criteria: Children who are on mechanical ventilation for a period of more than 24 hours, between 28 days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of the Children's Institute in Brazil Exclusion Criteria: * Upper Airway Obstruction * Diaphragmatic hernia or diaphragmatic paralysis * Chronic use of mechanical ventilation * Cyanogenic congenital heart disease * Primary pulmonary hypertension * Neuromuscular disease * Tracheostomy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of São Paulo General Hospital

São Paulo, BrazilOpen University of São Paulo General Hospital in Google Maps
CompletedOne Study Center