Skip to main content
OpenTrials
Completed

NCT Number: NCT04011852

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventilator Weaning Child Electrical Impedance Tomography Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Spontaneous Breathing Trial

Age range

28 day–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of São Paulo General Hospital

São Paulo, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrical impedance tomography

Device

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

Primary outcomes

  1. Correlate Electrical impedance tomography to Extubation failure

    Time frame: 48 hours

    Compare data obtained by the EIT during the spontaneous breathing trial with Extubation failure

  2. Correlate Electrical impedance tomography to spontaneous breathing trial failure

    Time frame: 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 outcomes

  1. Electrical impedance tomography Security

    Time frame: 2 hours

    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. Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2019
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.