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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011852
• Other study ID #: 10055719.0.0000.0068
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Child
• Electrical Impedance Tomography
• Respiratory Aspiration
• Spontaneous Breathing Trial
• Ventilator Weaning

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