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

NCT06844617 | Recruiting

• 1 other identifier: 333769
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Proning; Intensive Care Medicine

Keywords

BathMat; Proning; Proned; Repositioning; Intensive Care; ICU; ITU; Bath Mat

Outcome Measures

Primary Outcomes (1)

• Time taken to reposition

  Time taken from the time the first assistant arrives at the bedside to reposition until the repositioning exercise is completed.

  From enrollment until proning no longer clinically indicated, an average of 60 hours.

Secondary Outcomes (4)

• Assessment of the number of repositioning exercises undertaken for each patient within a proning intervention.

  From enrollment until proning no longer clinically indicated, an average of 60 hours.

• The number of minor or major adverse incidents associated with repositioning patients whilst in the prone position. This includes events such as line or tube displacement.

  From enrollment until proning no longer clinically indicated, an average of 60 hours.

• The manual handling requirement to reposition

  From enrollment until proning no longer clinically indicated, an average of 60 hours.

• In patients who suffered a major or minor adverse event (as defined in secondary outcome b), assessment of the healthcare costs relating to that event at 3 months following ICU discharge.

  3 months from enrollment

Study Arms (2)

Repositioning using standard care

NO INTERVENTION

Patients are repositioned while proned using standard care on each unit, every 2-4 hours.

Repositioning using BathMat

EXPERIMENTAL

Patients are repositioned using the BathMat, every 2-4 hours.

Device: BathMat

Interventions

BathMat DEVICE

Repositioning patients using the BathMat

Repositioning using BathMat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator

Study Sites (1)

North Bristol Trust

Bristol, BS10 5NB, United Kingdom

RECRUITING

Related Publications (1)

• Condry J, Georgiou A, Vangsgaard A, Mills H, Smith T, Hunt A, Lunt AJG. A randomised crossover trial of staff time with proned patients in the ICU using the 'BathMat'. Trials. 2025 Nov 13;26(1):503. doi: 10.1186/s13063-025-09221-x.

  PMID: 41233869 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Jerome Condry, MBBS

CONTACT

01225 428331; jerome.condry@nhs.net

Jane Carter

CONTACT

01225 428331; jane.carter14@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unconscious and unaware of which arm they are involved in. Due to the nature of the device, blinding of care providers or investigators is not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, multicentre, single blind crossover study of repositioning in ventilated proned patients in ICU using the BathMat vs conventional care.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 25, 2025
• Study Start: June 5, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 2025-June 2026
• Access Criteria: IPD and supporting information will be available once published

Locations

GB (1)