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AI-Crafted care plan aims to stop a common ICU harm

NCT ID NCT07789613

Prevention Sponsor: Koç University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a nursing care bundle created with the help of artificial intelligence can prevent medical device-related pressure injuries in intensive care patients. These injuries, which can be painful and serious, affect about 1 in 5 ICU patients. The study will compare the AI-synthesized bundle to routine care in 220 adults with medical devices, tracking who develops a pressure injury over up to 14 days. It also measures the cost of the intervention to see if it is a good value for hospitals.

What this could mean

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

Active substance
AI-synthesized nursing care bundle (a set of 3-5 evidence-based care components developed with AI assistance and expert input)
What this could lead to
If effective, this care bundle could become a standard, cost-effective way to prevent painful and serious pressure injuries in intensive care patients.
What could go wrong
This is a single-center trial with a relatively small sample, and the bundle's success depends on nurses following it consistently. Results may not apply to other hospitals 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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.

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: * Adults aged 18 years or older * Presence of at least one medical device placed for diagnostic or therapeutic purposes. * No existing medical device-related pressure injury (MDRPI) at the time of study enrollment. * Expected length of stay in the intensive care unit of at least 24 hours. * Willingness to participate in the study and provision of written informed consent by the participant or their legal representative. Exclusion Criteria: * Presence of only a peripheral intravenous (IV) catheter as a medical device. (Peripheral IV catheters are excluded because they are routinely present in ICU patients and their replacement frequency and treatment-related use may vary rapidly and unpredictably) * Presence of an existing MDRPI at the time of study enrollment. * Expected intensive care unit stay of less than 24 hours. * Refusal to participate, failure to provide informed consent, or withdrawal of consent during the study.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer prevention target

As listed by the trial registrant

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

Medical device related pressure ulcer (mdrpu) Pressure injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Koc University Hospital

    Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

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