Patients admitted to intensive care units (ICUs) are at increased risk of medical device-related pressure injuries (MDRPIs) due to the prolonged use of monitoring devices. Pulse oximeter probes are routinely used for continuous monitoring of oxygen saturation and pulse rate and may contribute to pressure injury development when left in the same position for extended periods . Current international guidelines recommend regular assessment of the skin and repositioning of medical devices but do not specify an optimal repositioning interval. This randomized controlled trial aims to evaluate the effect of different pulse oximeter probe replacement intervals on the development of pressure injuries in adult ICU patients. The findings are expected to provide evidence to guide clinical practice and improve the prevention of medical device-related pressure injuries.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older
* Written informed consent provided by the patient's legally authorized representative
* Patients monitored with a pulse oximeter in the intensive care unit (ICU)
* Glasgow Coma Scale (GCS) score of 8 or less
* Expected or actual ICU stay of more than 72 hours
Exclusion Criteria:
* Patients with severe peripheral edema
* Patients with dermatological conditions that impair skin integrity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site
Timeframe: Up to 4 hours after pulse oximeter probe placement