Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of Very Low Birth Weight (<1500 G) Neonates Using Electric Impedance Tomography

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; RDS of Prematurity; Prematurity; Very Low Birth Weight Infant; RDS - Infants
• Intervention / Treatment: Device: Lung electrical impedance tomography monitoring

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All neonates meeting eligibility criteria and treated in the Neonatal Intensive Care Unit will be invited to participate in the study. All subjects will be assessed, diagnosed and treated according to institutional guidelines.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1; Patients receiving invasive respiratory therapy (intubated)	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
Group2; Patients receiving non-invasive respiratory therapy.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predict criteria and preconditions for the successful extubation using electrical impedance tomography	Same as primary outcome	3 days

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Principal Investigator: Arūnas Liubšys, MD, Vilnius University

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: electrical impedance tomography
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Respiration Disorders; Premature Birth; Birth Weight; Respiratory Insufficiency
• Other Study ID Numbers: EIT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No