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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04542096
• Other study ID #: EIT-1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Prematurity
• RDS - Infants
• RDS of Prematurity
• Respiratory Failure
• Respiratory Insufficiency
• Very Low Birth Weight Infant

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.