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Can a simple monitor predict fluid needs in critically ill kids?

NCT ID NCT04186416

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether a device called Mostcare can predict if children need more fluids after surgery. Researchers will compare its readings with ultrasound measurements in 100 children aged 0-10 who are on breathing machines. The goal is to see if the device can help doctors give the right amount of fluid, avoiding harm from too little or too much.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mostcare® device (non-invasive monitoring) and transthoracic cardiac ultrasound
What this could lead to
If successful, this could help doctors better manage fluids in critically ill children, reducing complications from too much or too little fluid.
What could go wrong
This is a small, early-stage study (100 children) that only measures accuracy, not outcomes. The device may not work well in all children or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

19 people

The number who actually took part.

Started

May 2023

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients between birth and 10 years of age admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

Ages

Up to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children aged 0 to 10 years old, of both sexes. * Perioperative period of surgery under general anesthesia requiring admission to surgical resuscitation (before and / or after the surgical procedure). * Patients admitted for severe trauma. * Patient installation: supine position. * Intubation and mechanical ventilation: tidal volume: 7 to 8 ml / kg, Positive expiratory pressure : 3-4 cm H2O, inspiration / expiration: 1 / 1.5 to 1/2; respiratory rate: 1 month up to 2 years = 30 / min; children 2-8 years = 20 / min; children\> 8 years = 15 / min. * Patients with arterial catheters. * Need for a volume expansion : indication given by the doctor in charge of the patient. * Non-opposition expressed by the holders of parental authority. Exclusion Criteria: * Cardiac rhythm disorders (in particular atrial fibrillation, junctional tachycardia, ventricular arrhythmias), with the exception of sinus tachycardia, respiratory variations of heart rate and sporadic atrial / ventricular extrasystoles whom will allow inclusion. * Cardiopathy: severe systolic dysfunction (shortening fraction \<28%, ejection fraction \<50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct. * Unstable hemodynamic status related to active bleeding requiring vascular filling \> 2 mL / kg / min or requiring vasopressor or inotropic therapy whose dosage had to be changed in the last five minutes. * Need for mechanical ventilation with a tidal volume\> 10 mL / kg or \<7 mL / kg. * Refusal of the patient or the holders of parental authority to exploit the collected data. * Impossibility to carry out measurements.

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Conditions

The condition(s) this trial relates to.

Hemorrhage Hypovolemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fluid responsiveness Hemorrhage Hypovolemia

Contacts and locations

Locations

  • Hôpital Necker-Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.