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

V

Vilnius University

Status

Completed

Conditions

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

Treatments

Device: Lung electrical impedance tomography monitoring

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

22 to 36 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Group1
Description:
Patients receiving invasive respiratory therapy (intubated)
Treatment:
Device: Lung electrical impedance tomography monitoring
Group2
Description:
Patients receiving non-invasive respiratory therapy.
Treatment:
Device: Lung electrical impedance tomography monitoring

Trial contacts and locations

1

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Central trial contact

Arūnas Liubšys, MD; Ernestas Viršilas, MD

Data sourced from clinicaltrials.gov

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