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

May 10, 2024 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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • 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.

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

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
Intervention / Treatment
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

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

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)

December 14, 2016

Primary Completion (Actual)

July 6, 2017

Study Completion (Actual)

July 6, 2017

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimated)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC16_0161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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