A randomised crossover trial of staff time with proned patients in the ICU using the 'BathMat'.
Jerome Condry, Andy Georgiou, Anders Vangsgaard...
https://pubmed.ncbi.nlm.nih.gov/41233869Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06844617
A Trial of the Difference in Staff Time Involved in Repositioning Proned Patients in the ICU Using the 'BathMat' Compared With Standard Care
Led by Royal United Hospitals Bath NHS Foundation Trust · Updated on 2025-06-18
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
R
Royal United Hospitals Bath NHS Foundation Trust
Lead Sponsor
U
University of Bath
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new device called the BathMat to improve the repositioning process for very sick patients in Intensive Care Units (ICU) who need proning, a method of lying on the front to increase oxygen intake. Proning requires turning the patient's head and moving their arms every 2-4 hours to prevent pressure sores and injuries. This study aims to compare the BathMat device to standard care to see if it reduces staff time and risks involved in repositioning. The BathMat is an inflatable cushion placed under the patient that lifts their chest and hips, allowing safer and easier repositioning without sliding the patient on the bed. The study will involve 30 patients across up to four hospitals over 14 months. Patients will be positioned using both the BathMat and standard care methods in a randomized crossover design, with repositioning occurring every 2-4 hours during the proning period. Participants will be sedated, ventilated patients over 18 years old who require proning as determined by their ICU clinician. The study team will collect data on the time taken to reposition patients, the number of repositioning exercises, any adverse events like tube displacements, and manual handling requirements during the proning period, typically averaging 60 hours. Follow-up assessments of healthcare costs related to adverse events will also be done three months after ICU discharge, while staff will monitor device safety and usability throughout the study.
CONDITIONS
Brief Title
A Trial of Staff Time With Proned Patients in the ICU Using the 'BathMat'
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Any sedated, ventilated patient over 18 years of age identified as requiring proning by a senior ICU clinician
You will not qualify if you...
- Patients who are awake
- Patients who are pregnant
- Patients under guardianship
- Patients 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
- Patients weighing over 200 kg
- Patients under 150 cm or over 205 cm tall
- Patients who have already been proned using conventional methods in the current ICU admission
- Patients with broken skin on the anterior chest or abdominal wall
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - From enrollment until proning is no longer clinically indicated, an average of 60 hours
Participants are repositioned while proned using either the BathMat device or standard care every 2-4 hours during their ICU stay.
Multiple repositioning sessions every 2-4 hours during the treatment period
Follow-up
Duration - 3 months from enrollment
Participants who experienced adverse events related to repositioning will be assessed for healthcare costs 3 months after ICU discharge.
1 follow-up visit (in-person or remote) for healthcare cost assessment
Trial Site Locations
Total: 1 location
1
North Bristol Trust
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
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Research Team
J
Jerome Condry, MBBS
J
Jane Carter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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