PneumoniaBePeSEITNCT07319624
Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children
A study testing Electrical Impedence Tomography in people with Pneumonia and Tetralogy of Fallot Correction, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age. This population is challenging for its variety and anatomophysiologic peculiarity. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Pneumonia, Tetralogy of Fallot Correction, Caustics Ingestion
- What is being tested?
- Electrical Impedence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age under 3
- Impaired oxygenation - defined as an
- oxygenation Index (OI = mean airway pressure multiplied by FiO₂ divided by PaO₂) greater than 4; and/or
- an Oxygen Saturation Index (OSI = mean airway pressure multiplied by FiO₂ divided by SpO₂) greater than 5; or
- altered respiratory mechanics - defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.
Who cannot join
- thoracic fractures
- chest drains
- subcutaneous thoracic devices
- presence of intracardiac shunts
- confirmed or suspected pneumothorax on chest X-ray or lung ultrasound
- hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers.
Show all 9Show fewer
- technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability
- belt-to-chest size incompatibility (< 3 kg)
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Papa Giovanni XXIII Hospital, Bergamo, BG 24100
Bergamo, Italy, 24100
About this study
This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age. This population is challenging for its variety and anatomophysiologic peculiarity. A decremental PEEP trial using 1 cmH₂O steps following a recruitment maneuver at 35 cmH₂O was compared between EIT and other best PEEP assessment protocols.
Read the detailed description
The study enrolled consecutive patients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics. Impaired oxygenation sufficient for inclusion was defined as an oxygenation index (OI) greater than 4, defined as mean airway pressure multiplied by FiO₂ divided by PaO₂, and/or an oxygen saturation index (OSI), defined as mean airway pressure multiplied by FiO₂ divided by SpO₂, greater than 5. Altered respiratory mechanics sufficient for inclusion was defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.
Patients were excluded if they had contraindications to the placement of the EIT belt, such as thoracic fractures, chest drains, or subcutaneous thoracic devices. The presence of intracardiac shunts was also an exclusion criterion. Further exclusions included confirmed or suspected pneumothorax on chest X-ray or lung ultrasound, hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers. Technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability, belt-to-chest size incompatibility (< 3 kg), or the need for urgent clinical interventions, also led to exclusion. Lack of informed consent from parents or legal guardians precluded enrollment.
Study Protocol The stepwise PEEP titration protocol used in this study is partially part of a clinical approach routinely adopted in the PICU of our institution to optimize lung recruitment and individualize ventilator settings in mechanically ventilated children.
According this study protocol, once clinical stabilization was achieved - defined as adequate sedation and analgesia, cardiovascular stability, and appropriate patient-ventilator synchrony -neuromuscular blockade was administered. An EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the patient's weight was placed at the fourth or fifth intercostal space along the axillary line.
Baseline parameters were collected, including gas exchange data, respiratory mechanics, and ventilator settings (PEEP, tidal volume [Vt], respiratory rate, driving pressure [ΔP], compliance [Crs], FiO₂, SpO₂, OI or OSI), as well as blood gas analysis when available. PEEP was initially set according to the ARDSNet lower PEEP/higher FiO₂ table, referred to as PEEPnih. If children was volume-controlled ventilate, pressure-controlled ventilation was applied with an inspiratory pressure above PEEP equal to the baseline ΔP to maintain a similar Vt regardless of the previous ventilation mode.
A 5-minute EIT baseline recording was performed before initiating the recruitment maneuver.
The maneuver consisted of a sustained inflation at 35 cmH₂O, which was maintained until the global impedance curve displayed a plateau - suggestive of the end of a significant recruitment - or for a maximum duration of 25 seconds. This approach was introduced as a safety measure to avoid unnecessary overdistension and excessive intrathoracic pressures with potential hemodynamic impairment. The use of the impedance-time curve to guide the termination of the sustained inflation is consistent with the method described by Costa et al., which supports the identification of lung recruitment plateau using EIT-derived global impedance monitoring.
Following the recruitment maneuver, a decremental PEEP trial was conducted with 5-minute steps, starting from PEEPnih+4 cmH₂O and progressively decreasing by 1 cmH₂O increments down to PEEPnih-4 cmH₂O. The trial was discontinued early if the global ΔEELI signal dropped by more than 15%, indicating relevant decrease of the end-expiratory lung volume. The trial was also interrupted if clinical concerns arose, such as newly suspected pneumothorax or hemodynamic instability.
At each PEEP step, the following variables were recorded: heart rate, blood pressure, SpO₂, OSI, plateau pressure, ΔP, Vt, global Crs, and the percentage distribution of ventilation in the four ventral to dorsal regions of interest (ROIs). From these, compliance values for gravity-dependant (CrsD - dorsal regions) and non gravity-dependant (CrsND - ventral regions) regions were derived.
- Conditions
- Pneumonia, Tetralogy of Fallot Correction, Caustics Ingestion, Orthotopic Liver Transplantation
- Being tested
- Electrical Impedence Tomography
- Keywords
- EIT, PEEP, Mechanical Ventilation, Electrical Impedence Tomography, PARDS
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedence TomographyDiagnostic test
An EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the children's weight was placed at the fourth or fifth intercostal space along the axillary line.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Acute Respiratory Distress Syndrome (PARDS) patients | Experimental | Patients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics. Receives: Diagnostic Test: Electrical Impedence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (% of patients that complete the EIT-guided PEEP trial)
assessing the feasibility of an individualized PEEP titration using an EIT-guided decremental PEEP trial specifically designed for smaller children.
Measured: 20 weeks
Secondary outcomes (5)
To compare PEEPeit (cmH2O) with PEEPnih (cmH2O)
To compare PEEP levels determined by EIT (PEEPeit, cmH2O) with those recommended by NIH tables (PEEPnih, cmH2O) and those identified through the highest static compliance measurements (Compliance-guided method; PEEPCrs, cmH2O)
Measured: 20 weeks
To evaluate changes of EIT patterns of overdistension (%) and derecruitment (%) according to changes in respiratory system Compliance-guided method (mL/cmH2O)
To evaluate changes of EIT patterns of overdistension (%) and derecruitment (%) according to changes in respiratory system Compliance-guided method (mL/cmH2O)
Measured: 20 weeks
To assess changes in respiratory system compliance (mL/cmH2O) across different PEEP levels (cmH2O)
To assess changes in respiratory system compliance (mL/cmH2O) across different PEEP levels (cmH2O)
Measured: 20 weeks
To assess changes in end-expiratory lung impedance (arbitrary units) by EIT across different PEEP levels (cmH2O)
To assess changes in end-expiratory lung impedance (arbitrary units) by EIT across different PEEP levels (cmH2O)
Measured: 20 weeks
To assess changes in oxygenation (PaO2/FiO2, mmHg) across different PEEP levels
To assess changes in oxygenation (PaO2/FiO2, mmHg) across different PEEP levels
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Dec 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfio Bronco, Papa Giovanni XXIII Hospital
- Investigators
- Alfio Bronco, MD, Principal investigator, Papa Giovanni XXIII Hospital, Bergamo, BG 24100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319624
- Sponsor's protocol ID
- PETI
- Acronym
- BePeSEIT
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pediatric population sensitive data
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children
- ClinicalTrials.gov ID
- NCT07319624
- Acronym / sponsor ID
- BePeSEIT / PETI
- Conditions
- Pneumonia, Tetralogy of Fallot Correction, Caustics Ingestion, Orthotopic Liver Transplantation
- Keywords
- EIT, PEEP, Mechanical Ventilation, Electrical Impedence Tomography, PARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Jan 2026 (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.
This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age. This population is challenging for its variety and anatomophysiologic peculiarity. A decremental PEEP trial using 1 cmH₂O steps following a recruitment maneuver at 35 cmH₂O was compared between EIT and other best PEEP assessment protocols.
Detailed description
The study enrolled consecutive patients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics. Impaired oxygenation sufficient for inclusion was defined as an oxygenation index (OI) greater than 4, defined as mean airway pressure multiplied by FiO₂ divided by PaO₂, and/or an oxygen saturation index (OSI), defined as mean airway pressure multiplied by FiO₂ divided by SpO₂, greater than 5. Altered respiratory mechanics sufficient for inclusion was defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.
Patients were excluded if they had contraindications to the placement of the EIT belt, such as thoracic fractures, chest drains, or subcutaneous thoracic devices. The presence of intracardiac shunts was also an exclusion criterion. Further exclusions included confirmed or suspected pneumothorax on chest X-ray or lung ultrasound, hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers. Technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability, belt-to-chest size incompatibility (< 3 kg), or the need for urgent clinical interventions, also led to exclusion. Lack of informed consent from parents or legal guardians precluded enrollment.
Study Protocol The stepwise PEEP titration protocol used in this study is partially part of a clinical approach routinely adopted in the PICU of our institution to optimize lung recruitment and individualize ventilator settings in mechanically ventilated children.
According this study protocol, once clinical stabilization was achieved - defined as adequate sedation and analgesia, cardiovascular stability, and appropriate patient-ventilator synchrony -neuromuscular blockade was administered. An EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the patient's weight was placed at the fourth or fifth intercostal space along the axillary line.
Baseline parameters were collected, including gas exchange data, respiratory mechanics, and ventilator settings (PEEP, tidal volume [Vt], respiratory rate, driving pressure [ΔP], compliance [Crs], FiO₂, SpO₂, OI or OSI), as well as blood gas analysis when available. PEEP was initially set according to the ARDSNet lower PEEP/higher FiO₂ table, referred to as PEEPnih. If children was volume-controlled ventilate, pressure-controlled ventilation was applied with an inspiratory pressure above PEEP equal to the baseline ΔP to maintain a similar Vt regardless of the previous ventilation mode.
A 5-minute EIT baseline recording was performed before initiating the recruitment maneuver.
The maneuver consisted of a sustained inflation at 35 cmH₂O, which was maintained until the global impedance curve displayed a plateau - suggestive of the end of a significant recruitment - or for a maximum duration of 25 seconds. This approach was introduced as a safety measure to avoid unnecessary overdistension and excessive intrathoracic pressures with potential hemodynamic impairment. The use of the impedance-time curve to guide the termination of the sustained inflation is consistent with the method described by Costa et al., which supports the identification of lung recruitment plateau using EIT-derived global impedance monitoring.
Following the recruitment maneuver, a decremental PEEP trial was conducted with 5-minute steps, starting from PEEPnih+4 cmH₂O and progressively decreasing by 1 cmH₂O increments down to PEEPnih-4 cmH₂O. The trial was discontinued early if the global ΔEELI signal dropped by more than 15%, indicating relevant decrease of the end-expiratory lung volume. The trial was also interrupted if clinical concerns arose, such as newly suspected pneumothorax or hemodynamic instability.
At each PEEP step, the following variables were recorded: heart rate, blood pressure, SpO₂, OSI, plateau pressure, ΔP, Vt, global Crs, and the percentage distribution of ventilation in the four ventral to dorsal regions of interest (ROIs). From these, compliance values for gravity-dependant (CrsD - dorsal regions) and non gravity-dependant (CrsND - ventral regions) regions were derived.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Acute Respiratory Distress Syndrome (PARDS) patients | Experimental | Diagnostic Test: Electrical Impedence TomographyPatients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics. |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age under 3
- Impaired oxygenation - defined as an
Key exclusion criteria (9 listed)
- thoracic fractures
- chest drains
- subcutaneous thoracic devices
- presence of intracardiac shunts
- confirmed or suspected pneumothorax on chest X-ray or lung ultrasound
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 Impedence TomographyAn EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the children's weight was placed at the fourth or fifth intercostal space along the axillary line. | Diagnostic test | Pediatric Acute Respiratory Distress Syndrome (PARDS) patients |
Primary outcome
Feasibility (% of patients that complete the EIT-guided PEEP trial)
Time frame: 20 weeks
assessing the feasibility of an individualized PEEP titration using an EIT-guided decremental PEEP trial specifically designed for smaller children.
5 secondary outcomes
To compare PEEPeit (cmH2O) with PEEPnih (cmH2O)
Time frame: 20 weeks
To evaluate changes of EIT patterns of overdistension (%) and derecruitment (%) according to changes in respiratory system Compliance-guided method (mL/cmH2O)
Time frame: 20 weeks
To assess changes in respiratory system compliance (mL/cmH2O) across different PEEP levels (cmH2O)
Time frame: 20 weeks
To assess changes in end-expiratory lung impedance (arbitrary units) by EIT across different PEEP levels (cmH2O)
Time frame: 20 weeks
To assess changes in oxygenation (PaO2/FiO2, mmHg) across different PEEP levels
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided. Pediatric population sensitive data
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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. This study is not recruiting at the moment.
Alfio Bronco, MD principal investigator
Papa Giovanni XXIII Hospital, Bergamo, BG 24100
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedence Tomography in people with Pneumonia and Tetralogy of Fallot Correction, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jan 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (% of patients that complete the EIT-guided PEEP trial) (time frame: 20 weeks). 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 6 Jan 2026.