Positive End-expiratory Pressure (PEEP)NCT05612256
Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
An observational study of Positive End-expiratory Pressure (PEEP), run by University Children's Hospital Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Positive End-expiratory Pressure (PEEP)
- What is being tested?
- Electrical impedance tomography (EIT), Forced oscillation technique (FOT) and Saturation oxygenation pressure index (SOPI)
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Child
Study population: All newborn infants admitted to the University Children's Hospital Basel UKBB requiring mechanical ventilation are eligible for the study.
Who may be able to join
- 22+0 to 41+6 weeks' gestational age
- Requiring mechanical ventilation
- Written informed parental consent
Who cannot join
- Major congenital malformations including lung and cardiac malformations
- Infants on high frequency oscillatory ventilation
- Lack of written informed parental consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neonatology, University Children's Hospital Basel UKBB
Basel, 4031
Roland Gerull, Dr. med.
Roland Gerull, Dr. med.
About this study
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.
Read the 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.
- Conditions
- Positive End-expiratory Pressure (PEEP)
- Being tested
- Electrical impedance tomography (EIT), Forced oscillation technique (FOT), Saturation oxygenation pressure index (SOPI)
- Keywords
- respiratory support, newborn infants, ventilator induced lung injury (VILI), mechanical ventilation, electrical impedance tomography (EIT), forced oscillation technique (FOT), saturation oxygenation pressure index (SOPI), ventilation to perfusion ratio, regional lung ventilation patterns, Silent Spaces
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants on mechanical ventilation | Not described Receives: Diagnostic Test: Electrical impedance tomography (EIT); Diagnostic Test: Forced oscillation technique (FOT); Diagnostic Test: Saturation oxygenation pressure index (SOPI) | |
| Infants on non-invasive respiratory support | Not described Receives: Diagnostic Test: Electrical impedance tomography (EIT); Diagnostic Test: Saturation oxygenation pressure index (SOPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Secondary outcomes (10)
Change in Delta impedance (ΔZ)
Delta impedance (ΔZ) is an additional EIT parameter
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Once daily during the first three days on respiratory support and weekly intervals if the infant remains mechanically ventilated (approx. 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start10 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End-expiratory Pressure (PEEP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Gerull, Dr. med., Principal investigator, Department of Neonatology, University Children's Hospital Basel UKBB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612256
- Sponsor's protocol ID
- 2022-00508; ks22Gerull
- Status last verified
- May 2026
- First submitted
- 3 Nov 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants
- ClinicalTrials.gov ID
- NCT05612256
- Acronym / sponsor ID
- 2022-00508; ks22Gerull
- Conditions
- Positive End-expiratory Pressure (PEEP)
- Keywords
- respiratory support, newborn infants, ventilator induced lung injury (VILI), mechanical ventilation, electrical impedance tomography (EIT), forced oscillation technique (FOT), saturation oxygenation pressure index (SOPI), ventilation to perfusion ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants on mechanical ventilation | – | Diagnostic Test: Electrical impedance tomography (EIT), Diagnostic Test: Forced oscillation technique (FOT), Diagnostic Test: Saturation oxygenation pressure index (SOPI) |
| Infants on non-invasive respiratory support | – | Diagnostic Test: Electrical impedance tomography (EIT), Diagnostic Test: Saturation oxygenation pressure index (SOPI) |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- All newborn infants admitted to the University Children's Hospital Basel UKBB requiring mechanical ventilation are eligible for the study.
Key inclusion criteria (3 listed)
- 22+0 to 41+6 weeks' gestational age
- Requiring mechanical ventilation
- Written informed parental consent
Key exclusion criteria (3 listed)
- Major congenital malformations including lung and cardiac malformations
- Infants on high frequency oscillatory ventilation
- Lack of written informed parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Infants on mechanical ventilation, Infants on non-invasive respiratory support |
| 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 | Infants on mechanical ventilation |
| 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. | Diagnostic test | Infants on mechanical ventilation, Infants on non-invasive respiratory support |
Primary outcome
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)
A composite score consisting of proportionally weighted raw values of Silent Spaces, respiratory reactance (Xrs) and SOPI (mechanical ventilation)
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)
A composite score consisting of proportionally weighted raw values of Silent Spaces and SOPI (non-invasive respiratory support)
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)
Silent Spaces measured by EIT (calculated from electrical impedance)
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)
Respiratory reactance reflects inertance and compliance of the lungs and can be viewed as rebound resistance
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)
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)
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland Gerull, Dr. med. principal investigator
Department of Neonatology, University Children's Hospital Basel UKBB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Positive End-expiratory Pressure (PEEP), run by University Children's Hospital Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Gerull, Dr. med. (+41 61 70 42 307, Roland.Gerull@ukbb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.