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Recruiting NCT05612256

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

— Observational Positive End-expiratory Pressure (PEEP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical impedance tomography (EIT), Forced oscillation technique (FOT), Saturation oxygenation pressure index (SOPI).
Who it may be relevant to
Registry conditions: Positive End-expiratory Pressure (PEEP). Basic parameters: 0 Days — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

Evidence-based guidelines on the optimal level of positive end-expiratory pressure (PEEP) in newborn infants on respiratory support do not exist. Furthermore, there is a lack of simple bed-side parameters to guide clinicians towards the optimal PEEP level. Nevertheless, PEEP requires individual adjustment to minimize ventilator induced lung injury (VILI), shorten the duration of mechanical ventilation and reduce respiratory long-term morbidity.

Potential techniques to assess optimal PEEP level in infants on respiratory support include electrical impedance tomography (EIT), the forced oscillation technique (FOT) and the saturation oxygenation pressure index (SOPI). EIT is a promising non-invasive technique that provides information on regional changes in lung aeration and ventilation inhomogeneity. FOT is used in mechanically ventilated or spontaneously breathing infants and provides information on reactance (Xrs) and resistance (Rrs) of the respiratory system. SOPI is a score calculated from the PEEP level, the amount of administered oxygen (FiO2) and the infant's peripheral oxyhaemoglobin saturation (SpO2). SOPI provides information on the ventilation to perfusion ratio dependent on the PEEP level. EIT, FOT and SOPI seem promising tools for identification of optimal PEEP in newborn infants on respiratory support. In particular, a combination of information on regional ventilation (by EIT), global lung mechanics (by FOT) and ventilation to perfusion ratio (by SOPI) will improve the understanding of optimal PEEP and may reduce long-term respiratory sequelae.

This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI. Measurements are performed once daily during the first three days on respiratory support and are repeated in weekly intervals if the infant remains mechanically ventilated. An additional measurement is planned after extubation.

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 max
  • 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 commercial
  • 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.

Primary outcome measures

  • Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in Silent Spaces (areas of atelectasis as well as overdistension) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in Saturation oxygenation pressure index (SOPI) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
Secondary outcome measures (10)
  • Change in Delta impedance (ΔZ) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in centre of ventilation (CoV) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in tidal volume (VT,EIT) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in driving pressure of the respiratory system (Peak plateau pressure - PEEP) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in resistance (Rrs) of the respiratory system [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in peak inspiratory pressure [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in tidal volume per kg body weight (VT/kg) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in dynamic compliance [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in respiratory rate [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]
  • Change in transcutaneous CO2 pressure (tcpCO2) [Time frame: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)]

Eligibility criteria

Inclusion criteria

  • 22+0 to 41+6 weeks' gestational age
  • Requiring mechanical ventilation
  • Written informed parental consent

Exclusion criteria

  • Major congenital malformations including lung and cardiac malformations
  • Infants on high frequency oscillatory ventilation
  • Lack of written informed parental consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Department of Neonatology, University Children's Hospital Basel UKBB — Basel

Identifiers

NCT: NCT05612256 · 2022-00508; ks22Gerull

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗