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Recruiting NCT06844617

NCT06844617 A Trial of Staff Time With Proned Patients in the ICU Using the 'BathMat'

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Clinical Trial Summary
NCT ID NCT06844617
Status Recruiting
Phase
Sponsor Royal United Hospitals Bath NHS Foundation Trust
Condition Acute Respiratory Distress Syndrome (ARDS)
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2025-06-05
Primary Completion 2026-03-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
BathMat

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-06-05 with a primary completion date of 2026-03-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Proning is a way of helping people who are very sick and have trouble breathing. It involves lying patients on their front to get more oxygen into their body. This process happens in a part of the hospital called the Intensive Care Unit, and can last up to 16 hours per day. When in this position, doctors need to turn the patients' head and move their arms every 2-4 hours. Doctors call this repositioning. It helps prevent sores as well as other injuries. To do this, the health care team slide the patient up the bed, so that their (supported) head hangs over the end of the mattress. The head is then turned before the patient is slid back down the bed; their arms are then moved into a different position. This is currently performed by a team of 5+ staff and takes lots of time and resources. The process is also potentially dangerous because it requires a lot of movement which can hurt patients or staff. To make repositioning easier and safer, a group of doctors and engineers have created a new device. It is like a cushion that goes under the patient and inflates. This allows staff to reposition patients without needing to slide the patient on the bed. This also reduces the number of staff needed and lowers the risk to patients and staff. Feedback from staff, patients and the public are being used to help improve the system. To see if the new device works well in other hospitals, the investigators are planning to do a study with 30 patients in up to 4 different hospitals. This will last 14 months, and they will collect information on how well it performs. They will ask patients if they want to take part and will collect feedback after they leave hospital. During the study, staff from each hospital will monitor the device to make sure it is safe and record how useful it is. Any problems will be recorded, and staff will be asked for their opinions on how it affects their work. As well as monitoring safety, they will record the time saving achieved. This is important as it allows repositioning more often, which may reduce pressure sores. It also allows staff to spend more time focusing on other patients and important tasks. To share the results with other doctors, the researchers will write reports and give presentations. If successful, they will start making and selling the device to help sick patients on Intensive Care.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Jerome Condry, MBBS

✉ jerome.condry@nhs.net

📞 01225 428331

Frequently Asked Questions

Who can join the NCT06844617 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06844617 currently recruiting?

Yes, NCT06844617 is actively recruiting participants. Contact the research team at jerome.condry@nhs.net for enrollment information.

Where is the NCT06844617 trial being conducted?

This trial is being conducted at Bristol, United Kingdom.

Who is sponsoring the NCT06844617 clinical trial?

NCT06844617 is sponsored by Royal United Hospitals Bath NHS Foundation Trust. The trial plans to enroll 30 participants.

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