CompletedNot Applicable

Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients

United States20 participantsStarted 2023-12-06

Plain-language summary

Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV) children. Mechanically ventilated (MV) children approaching extubation as per the discretion of the PICU clinical team will undergo a positive end expiratory pressure (PEEP) titration protocol in a safe and timely manner in the PICU. During this PEEP titration, POCUS will be performed by a pediatric intensivist and interpreted by a pediatric cardiologist. Medical demographics will be collected from the electronic medical record and recorded.

Who can participate

Age range

3 Months – 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: * Patients admitted to Cohen Children's Medical Center (CCMC) PICU who are age 3 months - 18 years old who are invasively mechanically ventilated (oral or nasotracheally). * Patients on or approaching extubation readiness trial. * Patients with structurally normal heart. * Patients with normally functioning heart. * Consent by a legal guardian. Exclusion Criteria: * Patients with known air-leak syndrome. * Patients with history of congenital heart disease (CHD) (pre/post repair). * Patients with significant cardiac dysfunction and/or on vasoactive medications. * Patients with history of cardiomyopathy. * Patients with history of pulmonary hypertension. * Patients with history of chronic respiratory failure. * Patients with known mediastinal mass. * Patients with tracheostomy.

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

Tricuspid Regurgitant Jet Velocity

Timeframe: 30 minutes

Trial details

NCT IDNCT06229886

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

View on ClinicalTrials.gov More Tricuspid Regurgitation trials