- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542096
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Arūnas Liubšys, MD
- Phone Number: +3706 8722520
- Email: arunas.liubsys@santa.lt
Study Contact Backup
- Name: Ernestas Viršilas, MD
- Phone Number: +37060787438
- Email: ernestas.virsilas@santa.lt
Study Locations
-
-
-
Vilnius, Lithuania, 08661
- Recruiting
- Vilnius University Santaros Klinikos
-
Contact:
- Ernestas Viršilas, MD
- Phone Number: +37060787438
- Email: ernestas.virsilas@santa.lt
-
Contact:
- Arūnas Liubšys, MD
- Phone Number: +37068722520
- Email: arunas.liubsys@santa.lt
-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIT-1
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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