RecruitingNot Applicable

Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT)

United States60 participantsStarted 2024-12-10

Plain-language summary

The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows: Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations. Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP. Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.

Who can participate

Age range

0 Years – 18 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: * Any person who is less than 18 years of age * is on invasive mechanical ventilation * is not spontaneously breathing * meets PARDS criteria Exclusion Criteria: * Contraindication to the use of EIT * Hemodynamic instability * Contraindications to hypercapnia * patients with uncuffed endotracheal or tracheostomy tubes * diagnosis of pneumothorax or bronchopleural fistula * non-conventional ventilation * any patient on extra-corporeal membrane oxygenation (ECMO) support * less than 1 week post-operatively from cardiac surgery * the following cardiac diagnoses: Glenn or Fontan physiology, significant right to left shunt * Corrected Gestational Age \< 37 weeks * pregnancy

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

The absolute difference between the electrical impedence tomography (EIT) recommended PEEP and the PEEP recommended by the PEEP/fraction of inspired oxygen (FiO2) grid.

Timeframe: Day 1

Trial details

NCT IDNCT06684119

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Hayden Leeds, MD

3233617939 hleeds@chla.usc.edu

View on ClinicalTrials.gov More Pediatric Acute Respiratory Distress Syndrome trials