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

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.

Study Overview

• Status: Recruiting
• Conditions: Positive End-expiratory Pressure (PEEP)
• Intervention / Treatment: Diagnostic test: Electrical impedance tomography (EIT); Diagnostic test: Forced oscillation technique (FOT); Diagnostic test: Saturation oxygenation pressure index (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.

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

• Study Contact: Name: Roland Gerull, Dr. med.; Phone Number: +41 61 70 42 307; Email: Roland.Gerull@ukbb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department of Neonatology, University Children's Hospital Basel UKBB
    • Contact: Roland Gerull, Dr. med.
    • Principal Investigator: Roland Gerull, Dr. med.
    • Sub-Investigator: Roland Neumann, Dr. med.
    • Sub-Investigator: Benjamin Stöcklin, Dr. med.
    • Sub-Investigator: Sven Schulzke, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants on mechanical ventilation	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.
Infants on non-invasive respiratory support	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	A composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)	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)	Silent Spaces measured by EIT (calculated from electrical impedance)	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)	Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Change in Delta impedance (ΔZ)	Delta impedance (ΔZ) is an additional EIT parameter	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)	Centre of ventilation (CoV) is an additional EIT parameter	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)	Tidal volume (VT,EIT) is an additional EIT parameter	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)		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	Resistance (Rrs) is an additional FOT parameter	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	Peak inspiratory pressure is a mechanical ventilation parameters	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)	Tidal volume per kg body weight (VT/kg) is a mechanical ventilation parameters	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	Dynamic compliance is a mechanical ventilation parameters	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	Respiratory rate is a mechanical ventilation parameters	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)		Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Investigators: Principal Investigator: Roland Gerull, Dr. med., Department of Neonatology, University Children's Hospital Basel UKBB

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; electrical impedance tomography (EIT); newborn infants; respiratory support; ventilator induced lung injury (VILI); forced oscillation technique (FOT); saturation oxygenation pressure index (SOPI); ventilation to perfusion ratio; regional lung ventilation patterns; Silent Spaces
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 2022-00508; ks22Gerull

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No