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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Italy

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.

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 groups in NCT07319624
Study groupRoleWhat they receive
Pediatric Acute Respiratory Distress Syndrome (PARDS) patientsExperimentalPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted6 Jan 2026
  2. Study start1 Dec 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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)
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

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.

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