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New inflatable cushion could revolutionize ICU patient repositioning

NCT ID NCT06844617

Symptom relief Sponsor: Royal United Hospitals Bath NHS Foundation Trust Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests a new inflatable cushion called the BathMat, designed to help reposition patients lying on their stomachs (proned) in the ICU. Proning helps patients with severe breathing problems get more oxygen, but repositioning them every few hours currently requires at least 5 staff and can be risky. The BathMat aims to make this process faster, safer, and require fewer staff. The study will involve 30 patients across up to 4 hospitals to see if the device saves time and reduces harm.

What this could mean

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

Active substance
BathMat (inflatable cushion device)
What this could lead to
If successful, this device could make repositioning proned ICU patients quicker, safer, and require fewer staff, allowing more frequent repositioning and reducing pressure sores.
What could go wrong
This is a small early-stage trial with only 30 patients, so results may not apply broadly. The device may not prove safer or more efficient than standard care in larger studies.

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

30 people

The number who actually took part.

Started

Jun 2025

Finished

Aug 2026

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: Any sedated, ventilated patient over 18 years of age identified as requiring proning by a senior ICU clinician. Exclusion Criteria: Patients who are: * Awake * Pregnant * Under guardianship * In their first proning session in the current ICU admission who have already been repositioned 2 or more times using standard care prior to recruitment to the study. * Over 200 kg * Under 150cm and over 205cm * Patients who have already been proned using conventional methods in the current ICU admission * Patients who have broken skin on the anterior chest or abdominal wall

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome (ARDS) Intensive care medicine Proning

Contacts and locations

Locations

  • North Bristol Trust

    Bristol, BS10 5NB, United Kingdom

More trials for these conditions

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