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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorUniversity Children's Hospital Basel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

22+0 to 41+6 weeks' gestational age

Requiring mechanical ventilation

Written informed parental consent

Disqualifiers

Major congenital malformations including lung and cardiac malformations

Infants on high frequency oscillatory ventilation

Lack of written informed parental consent

Trial population

All newborn infants admitted to the University Children's Hospital Basel UKBB requiring mechanical ventilation are eligible for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrical impedance tomography (EIT)

    Diagnostic test

    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'.

  • Forced oscillation technique (FOT)

    Diagnostic test

    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.

  • Saturation oxygenation pressure index (SOPI)

    Diagnostic test

    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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Infants on mechanical ventilation3 interventions
Group B: Infants on non-invasive respiratory support2 interventions

Trial outcomes

Primary outcomes

1

Change in composite score consisting of proportionally weighted raw values of Silent Spaces, Xrs and SOPI (mechanical ventilation)

A composite score consisting of proportionally weighted raw values of Silent Spaces, respiratory reactance (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)
2

Change in composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)

A 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)
3

Change in Silent Spaces (areas of atelectasis as well as overdistension)

Silent Spaces measured by EIT (calculated from electrical impedance)

Time frame
Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
4

Change in respiratory reactance (Xrs) (measure of compliance of the respiratory system)

Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance

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 outcomes

1

Change in Delta impedance (ΔZ)

Delta impedance (ΔZ) is an additional EIT parameter

Time frame
Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
2

Change in centre of ventilation (CoV)

Centre of ventilation (CoV) is an additional EIT parameter

Time frame
Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
3

Change in tidal volume (VT,EIT)

Tidal volume (VT,EIT) is an additional EIT parameter

Time frame
Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
4

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)

Other outcomes

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