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

November 24, 2022 updated by: Arunas Liubsys, Vilnius University

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

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Vilnius, Lithuania, 08661
        • Recruiting
        • Vilnius University Santaros Klinikos
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arūnas Liubšys, MD
        • Sub-Investigator:
          • Ernestas Viršilas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
Patients receiving invasive respiratory therapy (intubated)
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.
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.
Time Frame: 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.
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.
Time Frame: 1 - 5 days.
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.
Time Frame: 1 - 5 days.
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
Time Frame: 3 days
Same as primary outcome
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arūnas Liubšys, MD, Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

September 1, 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)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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