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

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.

Study Overview

• Status: Completed
• Conditions: Child; Ventilator Weaning; Electrical Impedance Tomography; Spontaneous Breathing Trial
• Intervention / Treatment: Device: Electrical Impedance tomography

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 Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

• Study Contact: Name: Flávia K Foronda, MD PhD; Phone Number: +5511994440536; Email: flikrepel@foronda.com.br
• Study Contact Backup: Name: Leonardo R Fernandes, MD; Phone Number: +5511951164242

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil
      • University of Sao Paulo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 15 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 and are ready for a weaning trial.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Flávia K Foronda, MDPhD, Full staff

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Child; Ventilator Weaning; Respiration, artificial; Electrical Impedance Tomography; Intensive Care units
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 10055719.0.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No