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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04542096
Enrollment
72
Registered
2020-09-09
Start date
2020-09-29
Completion date
2024-05-20
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

electrical impedance tomography

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.

Interventions

DEVICELung 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

Sponsors

Vilnius University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Weeks to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Other

MeasureTime frameDescription
Predict criteria and preconditions for the successful extubation using electrical impedance tomography3 daysSame as primary outcome

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026