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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011852
Other study ID # 10055719.0.0000.0068
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2019
Est. completion date November 30, 2023

Study information

Verified date November 2023
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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%.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 28 Days to 15 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Brazil University of São Paulo General Hospital São Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlate Electrical impedance tomography to Extubation failure Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure 48 hours
Primary 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 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
Secondary 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
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