Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Ty… (NCT06999863) | Clinical Trial Compass
CompletedNot Applicable
Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm
France75 participantsStarted 2025-07-24
Plain-language summary
For accurate measurements of arterial blood pressure (BP), international guidelines recommend placing the automated oscillometric cuff directly on the bare upper arm. However, for various reasons, cuffs are often applied over a layer of textile. Whether this practice affects the reliability of the readings remains uncertain. Using a rigorous methodology, the CASBA study aims at addressing this issue.
Additionally, two different BP measurement algorithms are available in some oscillometric monitors. To our knowledge, no study has compared the performance of these two algorithms. This study will help determine which oscillometric algorithm should be given priority in intensive care facilities.
Who can participate
Age range
18 Years – 99 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:
* \- Patients having a catheter in the radial artery.
* and with stable BP over a 5-min period (no change in invasive MBP \>10% and no change in vasoactive drugs)
Exclusion Criteria:
* \- Cardiac arrhythmia.
* Dysfunctional of the arterial catheter or waveform, suggesting signal over- or under-damping.
* Arm circumference \> 42 cm (measured at mid-arm).
* Contraindication to BP measurement on the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access on the limb preventing cuff inflation, other).
* Patient's health status requiring urgent care incompatible with study protocol.
* Asymmetry of MBP between the two arms (\>5 mmHg) or inability to check it.
* Pregnant woman.
* Age \<18 years old.
* Adult known to be under guardianship or legal supervision before inclusion.
* Absence of social security coverage.
* Non-French speaker patient (i.e. unable to receive study information)
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
To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve