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

NCT ID: NCT04011852

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-26

Study Completion Date

2023-11-30

Brief Summary

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To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure.

Observe if the EIT monitoring will be 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.

Detailed Description

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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%.

Conditions

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Ventilator Weaning Child Spontaneous Breathing Trial Electrical Impedance Tomography

Keywords

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Ventilator Weaning Child Electrical Impedance Tomography Respiration, artificial Intensive Care units

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Electrical Impedance tomography

Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flávia K Foronda, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Full staff

Locations

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University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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10055719.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id