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Can a smart algorithm replace expert judgment for critical heart pressure readings?

NCT ID NCT07703592

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

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests whether an automated algorithm called SmartWedge can accurately measure pulmonary artery occlusion pressure (PAOP) in intensive care patients with septic shock. PAOP is a key measurement for guiding treatment, but manual readings can vary. The trial compares the algorithm's readings to those of an expert, using data from 30 patients who already have a Swan-Ganz catheter in place. The goal is to see if the automated method is reliable enough for routine use.

What this could mean

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

Active substance
Swan-Ganz IQ™ catheter with SmartWedge algorithm for automated pulmonary artery occlusion pressure measurement
What this could lead to
If the SmartWedge algorithm proves reliable, it could reduce measurement errors and improve consistency in monitoring heart function in critically ill patients.
What could go wrong
This is a small, early-stage study (30 participants) focused on agreement, not outcomes. The algorithm may not perform well in all clinical situations, such as during mechanical ventilation or arrhythmias.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

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 hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.

Ages

18 years and older

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: * Age ≥18 years; * Admission to an intensive care unit; * Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of patient care; * Measurement of pulmonary artery occlusion pressure (PAOP) performed by the attending clinician as part of patient care. Exclusion Criteria: * Pregnancy; * Court-ordered protective measures. * Refusal to participate by the patient's family members or the patient themselves. * Cardiac output measurements by thermodilution or by continuous cardiac output analysis that cannot be interpreted.

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

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

Septic shock

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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