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

NCT02991703 | Completed

• 1 other identifier: RC16_0161
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis

Keywords

Arterial stiffness; pulse wave velocity; Sphygmocor; applanation tonometry; pOpmètre; children; EPIPAGE cohort

Outcome Measures

Primary Outcomes (1)

• Difference between the two simultaneous measurements of velocity of the pulse wave by the pOpmeter® and the Sphygmocor®.

  Day One

Study Arms (2)

SphygmoCor®

ACTIVE COMPARATOR

Device: Sphygmocor

pOpmètre®

EXPERIMENTAL

Device: pOpmètre®

Interventions

pOpmètre® DEVICE

the pOpmètre® uses saturation sensors,

pOpmètre®

Sphygmocor DEVICE

the Sphygmocor uses applanation tonometry

SphygmoCor®

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children between 4 and 8 years old hospitalized in the Mother and Children Hospital in Nantes during the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Related Publications (8)

• Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.

  PMID: 16461839 BACKGROUND

• Urbina EM, Williams RV, Alpert BS, Collins RT, Daniels SR, Hayman L, Jacobson M, Mahoney L, Mietus-Snyder M, Rocchini A, Steinberger J, McCrindle B; American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Noninvasive assessment of subclinical atherosclerosis in children and adolescents: recommendations for standard assessment for clinical research: a scientific statement from the American Heart Association. Hypertension. 2009 Nov;54(5):919-50. doi: 10.1161/HYPERTENSIONAHA.109.192639. Epub 2009 Sep 3.

  PMID: 19729599 BACKGROUND

• Ancel PY, Goffinet F; EPIPAGE 2 Writing Group. EPIPAGE 2: a preterm birth cohort in France in 2011. BMC Pediatr. 2014 Apr 9;14:97. doi: 10.1186/1471-2431-14-97.

  PMID: 24716860 BACKGROUND

• Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.

  PMID: 20530030 BACKGROUND

• Reusz GS, Cseprekal O, Temmar M, Kis E, Cherif AB, Thaleb A, Fekete A, Szabo AJ, Benetos A, Salvi P. Reference values of pulse wave velocity in healthy children and teenagers. Hypertension. 2010 Aug;56(2):217-24. doi: 10.1161/HYPERTENSIONAHA.110.152686. Epub 2010 Jun 21.

  PMID: 20566959 BACKGROUND

• Curcio S, Garcia-Espinosa V, Arana M, Farro I, Chiesa P, Giachetto G, Zocalo Y, Bia D. Growing-Related Changes in Arterial Properties of Healthy Children, Adolescents, and Young Adults Nonexposed to Cardiovascular Risk Factors: Analysis of Gender-Related Differences. Int J Hypertens. 2016;2016:4982676. doi: 10.1155/2016/4982676. Epub 2016 Feb 18.

  PMID: 26989504 BACKGROUND

• Alivon M, Vo-Duc Phuong T, Vignon V, Bozec E, Khettab H, Hanon O, Briet M, Halimi JM, Hallab M, Plichart M, Mohammedi K, Marre M, Boutouyrie P, Laurent S. A novel device for measuring arterial stiffness using finger-toe pulse wave velocity: Validation study of the pOpmetre(R). Arch Cardiovasc Dis. 2015 Apr;108(4):227-34. doi: 10.1016/j.acvd.2014.12.003. Epub 2015 Feb 11.

  PMID: 25682547 BACKGROUND

• Bichali S, Bruel A, Boivin M, Roussey G, Romefort B, Roze JC, Allain-Launay E. Simplified pulse wave velocity measurement in children: Is the pOpmetre valid? PLoS One. 2020 Mar 27;15(3):e0230817. doi: 10.1371/journal.pone.0230817. eCollection 2020.

  PMID: 32218581 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 13, 2016
• Study Start: December 14, 2016
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: May 13, 2024

Record last verified: 2018-05