Simplified Pulse Wave Velocity Measurement, Validation Study of the pOpmètre in Children (NCT02991703) | Clinical Trial Compass
CompletedNot Applicable
Simplified Pulse Wave Velocity Measurement, Validation Study of the pOpmètre in Children
France60 participantsStarted 2016-12-14
Plain-language summary
Arterial stiffness is an important marker of cardiovascular risk. It is measured by pulse wave velocity. The reference device to measure pulse wave velocity is the Sphygmocor which uses applanation tonometry. It is used in adults and children. An easier method called pOpmètre using saturation sensors is validated in adults but not in children. The objective of this study is to compare the pulse wave velocity values measured with the pOpmètre® with those of the SphygmoCor® to validate the pOpmètre in children between 4 and 8 years old.
Who can participate
Age range
4 Years – 8 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:
* children between 4 and 8 years old hospitalized in the Mother and Children Hospital in Nantes during the study period.
Exclusion Criteria:
* Vasoconstrictor treatment,
* compressive bandage on the measured area,
* peripheral venous access on the measured side,
* vascular surgery or pathology on the measured area,
* significant pain or agitation,
* parental or legal representative disapproval,
* child disapproval.
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
Difference between the two simultaneous measurements of velocity of the pulse wave by the pOpmeter® and the Sphygmocor®.