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

Study Overview
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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%.

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

Conditions
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Ventilator Weaning, Child, Spontaneous Breathing Trial, Electrical Impedance Tomography

Intervention / Treatment
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* Device: Electrical Impedance tomography


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrical Impedance tomography|Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate Electrical impedance tomography to Extubation failure | Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure | 48 hours | 
| Correlate Electrical impedance tomography to spontaneous breathing trial failure | Observe if Electrical impedance tomography detects children who will fail in spontaneous breathing trial (during a 1-hour T-piece) earlier than clinical criteria | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical impedance tomography Security | Evaluate Electrical impedance tomography Security (skin lesion or pain) Neonatal Skin Condition Score Dryness Normal, no sign of dry skin Dry skin, visible scaling Very dry skin, cracking/fissures Erythema No evidence of erythema Visible erythema, < 50% body surface Visible erythema, ≥ 50% body surface Breakdown None evident Small, localized areas Extensive Note: Perfect score = 3 Worst score = 9 | 2 hours | 
| Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta | Verify whether traditional measures of tidal volume and the RR / VT index can be independently and accurately assessed through the measurement of Z-delta and RR / Z-delta, through the Electrical impedance tomography. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilator Weaning, Child, Electrical Impedance Tomography, Respiration, artificial, Intensive Care units