Simplified Pulse Wave Velocity Measurement, Validation Study of the pOpmètre in Children (EPIPOP)

September 10, 2026 updated by: Nantes University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prematurity is associated with an increased risk of developing cardio-vascular diseases in adulthood : a low birth weight linked to prematurity is correlated to a higher coronary disease mortality rate, a higher blood pressure level in adulthood, to abnormal glucose metabolism regulation, and to signs of nephron reduction. An independent marker of cardiovascular risk is arterial stiffness: it is associated with a higher risk of major cardiovascular events including stroke, acute coronary syndrome and complications of end-stage renal disease. It is measured by pulse wave velocity which is the gold standard in adulthood. Pulse wave velocity is also correlated to cardiovascular risk in childhood. National cohort EPIPAGE II is made of 4290 premature babies born in 2011. A study is scheduled at 5 years old and a half including a medical examination and a neuropsychological evaluation. An ancillary study lengthening medical consultation for 15 minutes is scheduled with 750 to 1000 of these children for a more precise vascular evaluation including pulse wave velocity. Different methods can be used to measure pulse wave velocity in children: these include applanation tonometry devices such as the SphygmoCor ® system. Its reference values are well known in adulthood and were determined more recently in childhood. It is the reference device but it is expensive, can be used only in expert health centres and time of measurement is long. In children, an easier-to-use and faster device would be more advantageous. The pOpmètre® uses 2 distal oxygen saturation sensors on finger and toe to deduce pulse wave velocity. This device has already been validated in adults. The aim of this study is to validate the pOpmètre in children between 4 and 8 years old. In that purpose, patients are installed in the supine position, at rest. The child's mensurations are measured. The two pOpmètre sensors are put on finger and toe. Blood pressure is measured by an armband on the right limb. Then another armband is put around the thigh and a tonometer is applied on the right carotid which allows pulse wave velocity measuring by the Sphygmocor. Pulse wave velocity is measured with the pOpmètre using the time delay between finger pulse signal and toe pulse signal. The values got with the two devices are compared using a Bland and Altman graph. The pOpmètre is considered to be validated if the 95% confidence interval of the bias is included between -0.5 m/sec and 0.5 m/sec that is about 10% of the normal value at that age (5.0 m/s +/-0.13).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nantes, France, 44093
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SphygmoCor®
Device: Sphygmocor
the Sphygmocor uses applanation tonometry
Experimental: pOpmètre®
Device: pOpmètre®
the pOpmètre® uses saturation sensors,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Difference between the two simultaneous measurements of velocity of the pulse wave by the pOpmeter® and the Sphygmocor®.
Time Frame: Day One
Day One

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC16_0161

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