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New device reads heartbeats to detect pain in silent patients

NCT ID NCT05454202

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called ANI that measures heart rate changes to assess comfort in patients who cannot speak, such as those in end-of-life care. Twenty non-communicating patients in a palliative care unit were monitored during a painful procedure. The device's readings were compared to standard pain scores from nurses to see if it could reliably detect discomfort.

What this could mean

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

Active substance
ANI monitor (device that measures heart rate variability to assess comfort)
What this could lead to
If successful, this could give doctors a reliable way to check comfort in patients who cannot speak, improving end-of-life care.
What could go wrong
This is a very small, early study (20 people) and the device is not yet proven for this specific use. It may not work better than current methods.

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

20 people

The number who actually took part.

Started

Sep 2022

Finished

May 2024

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

Non-communicating end-of-life patient hospitalized in palliative 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: * Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10) Exclusion Criteria: * Non sinusal heart rate * Respiratory rate \< 9/min * Treated by inotropes * Pace-maker * Patient in agonal phase * Opposition from the guardian

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hop Cardiologique Chu Lille

    Lille, France

More trials for these conditions

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