Etude Prospective Observationnelle Multicentrique Sur Volontaires Sains Des VALeurs de Pression Artérielle mesurées Sur Trois Sites alteRnAtIfS Des Membres inférieurs cOmparées au Site de référence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Locations
- 8
Study Overview
Brief Summary
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial).
The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible .
We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm.
It is also assessing the impact of certain parameters on the primary endpoint:
- Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures.
- A parameter related to measurement: discomfort felt when the blood pressure outlet.
- Exposure setting: smoking.
Detailed Description
Primary Outcome: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb.
Secondary endpoints: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb in the following subgroups:
- Male / Female
- BMI <25 / BMI> 25
- Size < 160 cm / size [160-169] cm / size [170-180] cm / size [181-190] cm / size ≥ 191 cm
- Age <25 years / age ≥ 25 years
- Systolic Blood Pressure value (SAP) the reference site <100 mmHg / 100 mmHg and ≥ NOT value of the reference site <140 mmHg / ≥ 140 mmHg
- Visual Analog Scale of discomfort ≤ 4/10 /> 4/10
- Hemibody studied Right / Left
- Smoking / No Smoking
Discomfort level depending on the measurement site of blood pressure in the general population.
- Discomfort level for each measurement of blood pressure site in each of the following subgroups:
- Male / Female - BMI <25 / BMI> 25
- size <160 cm / size [160-169] cm / size [170 -180] cm / size [181-190] cm / size ≥ 191 cm - Age <25 / age ≥ 25 years
- blood pressure value (SAP) reference site <100 mmHg / 100 mmHg and ≥ NOT Value reference site <140 mmHg / ≥ 140 mmHg
- hemibody studied Right / Left
- Smoking / No Smoking
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged 18 and over, without upper age limit
- •Recipient of a social protection scheme or entitled
- •Signature of informed consent
Exclusion Criteria
- •During Pregnancy
- •known disease
- •current treatment
- •cardiovascular history
- •Skin lesions in relation to the measurement sites
- •Special anatomically incompatible with blood pressure measurements
- •No one opposing the use of their data
- •Participation in a trial Ongoing clinical
- •Person who participated in the study
Investigators
Steven Lagadec
Principal Investigator
Centre Hospitalier Sud Francilien