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

Completed

• Conditions: RDS of Prematurity; Very Low Birth Weight Infant; Respiratory Failure; Prematurity; RDS - Infants
• Interventions: Device: Lung electrical impedance tomography monitoring

• Registration Number: NCT04542096
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2020-09-29
• Status Verified: 2022-11
• Primary Completion: 2024-04-20
• Study Completion: 2024-05-20
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group2	Lung electrical impedance tomography monitoring	Patients receiving non-invasive respiratory therapy.
Group1	Lung electrical impedance tomography monitoring	Patients receiving invasive respiratory therapy (intubated)

Primary Outcome Measures

Name	Time	Method
To evaluate the lung aeration properties of very low birth weight neonates using different respiratory therapy methods and regimens.	1 - 5 days.	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the characteristics of lung aeration during routine nursing care in preterm very low birthweight infants receiving respiratory support.	1 - 5 days.	Same as primary outcome.
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.	Same as primary outcome

Trial Locations

Locations (1)

Vilnius University Santaros Klinikos; 🇱🇹 Vilnius, Lithuania