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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-29

Study Completion Date

2024-05-20

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1

Patients receiving invasive respiratory therapy (intubated)

Lung electrical impedance tomography monitoring

Intervention Type DEVICE

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.

Lung electrical impedance tomography monitoring

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Gestational age \<32 weeks OR birthweight \<1500 g.
* Need of respiratory therapy (invasive or non-invasive)
* Parental consent.

* patients with a pacemaker
* patients with skin damage/abrasions at the EIT device belt area
* newborns with significant thoracic deformity

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No