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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04542096
Other study ID # EIT-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2020
Est. completion date September 2024

Study information

Verified date November 2022
Source Vilnius University
Contact Arunas Liubšys, MD
Phone +3706 8722520
Email arunas.liubsys@santa.lt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date September 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 22 Weeks to 36 Weeks
Eligibility Inclusion Criteria: - Gestational age <32 weeks OR birthweight <1500 g. - Need of respiratory therapy (invasive or non-invasive) - Parental consent. Exclusion Criteria: - patient does not meet all of the above listed inclusion criteria - patients with a pacemaker - patients with skin damage/abrasions at the EIT device belt area - newborns with significant thoracic deformity

Study Design


Intervention

Device:
Lung electrical impedance tomography monitoring
A belt for recording changes in electrical impedance in the skin will be fastened for the purpose of this study with no other additional procedures

Locations

Country Name City State
Lithuania Vilnius University Santaros Klinikos Vilnius

Sponsors (1)

Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Other Predict criteria and preconditions for the successful extubation using electrical impedance tomography Same as primary outcome 3 days
Primary To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens. Lung aeration and ventilation will be assessed with EIT. Several methods will be used and compared, based on pixel information of lung aeration, and pressure-volume characteristics, regional ventilation distribution and etc. 1 - 5 days.
Secondary To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support. Same as primary outcome. 1 - 5 days.
Secondary To compare lung aeration and regional ventilation distribution between two non-invasive respiratory therapies, constant positive pressure and high-flow nasal cannula in very low birthweight neonates. Same as primary outcome 1 - 5 days.
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