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

NCT04542096 | Completed

• 1 other identifier: EIT-1
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

RDS - Infants; RDS of Prematurity; Respiratory Failure; Prematurity; Very Low Birth Weight Infant

Keywords

electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.

  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.

  1 - 5 days.

Other Outcomes (1)

• Predict criteria and preconditions for the successful extubation using electrical impedance tomography

  3 days

Study Arms (2)

Group1

Patients receiving invasive respiratory therapy (intubated)

Device: Lung electrical impedance tomography monitoring

Group2

Patients receiving non-invasive respiratory therapy.

Device: Lung electrical impedance tomography monitoring

Interventions

Lung electrical impedance tomography monitoring DEVICE

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

Group1; Group2

Eligibility Criteria

• Age: 22 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Gestational age \<32 weeks OR birthweight \<1500 g.
• Need of respiratory therapy (invasive or non-invasive)
• Parental consent.

You may not qualify if:

• patients with a pacemaker
• patients with skin damage/abrasions at the EIT device belt area
• newborns with significant thoracic deformity

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Santaros Klinikos

Vilnius, Vilnius County, 08661, Lithuania

Location

Related Publications (1)

• Virsilas E, Liubsys A, Janulionis A, Valiulis A. Noninvasive Respiratory Support Effects on Sighs in Preterm Infants by Electrical Impedance Tomography. Indian J Pediatr. 2023 Jul;90(7):665-670. doi: 10.1007/s12098-022-04413-8. Epub 2022 Dec 21.

  PMID: 36539568 DERIVED

MeSH Terms

Conditions

RDS - infants; Respiratory Distress Syndrome In Premature Infants; Respiratory Insufficiency; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Arūnas Liubšys, MD

  Vilnius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arūnas Liubšys MD, PhD

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: September 29, 2020
• Primary Completion: April 20, 2024
• Study Completion: May 20, 2024
• Last Updated: March 28, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)