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New ultrasound tool could predict bedsores before they form

NCT ID NCT07496411

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 Results may not be published yet.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

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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an ultrasound-based risk score can better predict and prevent pressure injuries (bedsores) in critically ill ICU patients. In phase 1, researchers will check how accurately the score identifies high-risk patients. In phase 2, some patients will receive nursing care guided by the ultrasound score, while others get standard care. The goal is to see if the new approach reduces bedsores.

What this could mean

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

Active substance
Ultrasound-based Quantitative Risk Score-guided Nursing Intervention
What this could lead to
If successful, this could provide a more accurate way to predict and prevent pressure injuries in critically ill patients, reducing suffering and healthcare costs.
What could go wrong
This is an early-stage study with only 390 participants. The ultrasound score may not prove more effective than current methods, and results may not apply to all ICU 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 390 people

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

Expected to start

Mar 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.

Phase 1: Tool Development and Validation (Observational) Inclusion Criteria (Phase 1): 1. Age \> 18 years. 2. Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours. 3. Intact skin in the sacrococcygeal region within 24 hours of ICU admission. 4. Provision of signed informed consent. Exclusion Criteria (Phase 1): 1. Pregnant women or children. 2. Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound. 3. Clinical instability preventing lateral repositioning for ultrasound. 4. History of major sacrococcygeal surgery or severe trauma. 5. Life expectancy \< 48 hours. Phase 2: Randomized Controlled Trial (Interventional) Inclusion Criteria (Phase 2): 1. Meet all the general inclusion criteria from Phase 1. 2. Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results. Exclusion Criteria (Phase 2): 1. Meet all the general exclusion criteria from Phase 1. 2. Previous participation in Phase 1 of this study (to maintain independent samples for the RCT). 3. Current participation in other interventional trials that may impact pressure injury outcomes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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