Simplified Pulse Wave Velocity Measurement, Validation Study of the pOpmètre in Children
Condition: Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis
Study type: Interventional

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.
    

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).
    

Intervention name(s): pOpmètre®; Sphygmocor
Intervention type(s): Device; Device
Intervention description(s): the pOpmètre® uses saturation sensors,; the Sphygmocor uses applanation tonometry
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arterial stiffness; pulse wave velocity; Sphygmocor; applanation tonometry; pOpmètre; children; EPIPAGE cohort