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

Completed

• Conditions: Ventilator Weaning; Child; Spontaneous Breathing Trial; Electrical Impedance Tomography

• Registration Number: NCT04011852
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed 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%.

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-09
• Study Start: 2019-09-26
• Status Verified: 2023-11
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Electrical impedance tomography Security	2 hours	Evaluate Electrical impedance tomography Security (skin lesion or pain); Neonatal Skin Condition Score; Dryness; 1. Normal, no sign of dry skin; 2. Dry skin, visible scaling; 3. Very dry skin, cracking/fissures; Erythema; 1. No evidence of erythema; 2. Visible erythema, \< 50% body surface; 3. Visible erythema, ≥ 50% body surface; Breakdown; 1. None evident; 2. Small, localized areas; 3. Extensive; Note: Perfect score = 3 Worst score = 9
Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta	1 hour	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.

Trial Locations

Locations (1)

University of São Paulo General Hospital; 🇧🇷 São Paulo, Sao Paulo, Brazil