Clinical trial NCT04011852: The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Official title: The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Weaning
Child
Spontaneous Breathing Trial
Electrical Impedance Tomography
Keywords: Ventilator Weaning
Child
Electrical Impedance Tomography
Respiration, artificial
Intensive Care units
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 83
Sex: ALL
Minimum age (years): 28
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Correlate Electrical impedance tomography to Extubation failure
timeFrame: 48 hours
measure: Correlate Electrical impedance tomography to spontaneous breathing trial failure
timeFrame: 1 hour
Secondary outcomes:
measure: Electrical impedance tomography Security
timeFrame: 2 hours
measure: Compare tidal volume and RR / VT index with Z-delta and RR / Z-delta
timeFrame: 1 hour
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
state: Sao Paulo
Study officials:
affiliation: Full staff
name: Flávia K Foronda, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: