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Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants

NCT05612256 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-05-08

No results posted yet for this study

Summary

Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.

Conditions

  • Positive End-expiratory Pressure (PEEP)

Interventions

DIAGNOSTIC_TEST

Electrical impedance tomography (EIT)

EIT is the measurement of impedance changes of the lung against the flow of alternating electrical currents applied to the thorax. The signal of the electrodes is transmitted to a monitor, which enables real-time assessment of lung aeration and changes in lung volume. EIT is able to reconstruct impedance changes with a high temporal resolution and allows calculation of tidal volumes, relative stretch of lung tissue and areas of poor ventilation. Areas with impedance changes of \< 10 % of the maximum impedance changes are called 'Silent Spaces'.

DIAGNOSTIC_TEST

Forced oscillation technique (FOT)

FOT enables non-invasive assessment of lung mechanics using sound waves to inform about the respiratory impedance of the respiratory system (Zrs). Reactance of the respiratory system (Xrs) as part of Zrs is a surrogate measure of compliance of the respiratory system. Xrs was previously used to identify optimal PEEP level, i.e., the PEEP at highest compliance equivalent, in newborn infants using a setup requiring research-specific hardware and software. The FOT module integrated in the commercially available neonatal ventilator is routinely used. FOT measurements are performed twice at each PEEP level to assess the reproducibility of the measurements.

DIAGNOSTIC_TEST

Saturation oxygenation pressure index (SOPI)

SOPI is assessed non-invasively and calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) / SpO2). SOPI is used to provide information on ventilation to perfusion ratio dependent on PEEP level.

Sponsors & Collaborators

  • University Children's Hospital Basel

    lead OTHER

Principal Investigators

  • Roland Gerull, Dr. med. · Department of Neonatology, University Children's Hospital Basel UKBB

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612256 on ClinicalTrials.gov