CompletedNot Applicable

Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children

Italy14 participantsStarted 2024-12-01

Plain-language 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. 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.

Who can participate

Age range

0 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility (% of patients that complete the EIT-guided PEEP trial)

Timeframe: 20 weeks

Trial details

NCT IDNCT07319624

SponsorPapa Giovanni XXIII Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

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