Study on Pressure Values Measured on Three Alternative Sites of the Lower Limbs Compared to the Arm

NCT02529735 | Unknown

• 1 other identifier: CHSFrancilien
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Blood Pressure

Keywords

blood pressure; alternative measure

Interventions

efficiency study OTHER

Blood pressure values measured for comparative lower limb and arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and over, without upper age limit
• Recipient of a social protection scheme or entitled
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (8)

Sud Francilien Nursing School

Corbeil-Essonnes, 91100, France

AVAILABLE

Perray-Vaucluse Nursing School

Épinay-sur-Orge, 91360, France

AVAILABLE

Nursing Scool Barthelemy Durand

Étampes, 91150, France

AVAILABLE

SSSM of Essonne SDIS91

Évry, 91000, France

AVAILABLE

Nursing School of Longjumeau

Longjumeau, 91160, France

AVAILABLE

Nursing School Tenon

Paris, 75020, France

AVAILABLE

Nursing School Rambouillet

Rambouillet, 78120, France

AVAILABLE

Nursing School Foch

Suresnes, 92151, France

AVAILABLE

Related Publications (5)

• Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.

  PMID: 20890190 RESULT

• Block FE, Schulte GT. Ankle blood pressure measurement, an acceptable alternative to arm measurements. Int J Clin Monit Comput. 1996 Aug;13(3):167-71. doi: 10.1023/a:1016997232542.

  PMID: 8912031 RESULT

• Sanghera S, North A, Abernethy S, Wrench I. Arm and ankle blood pressure during caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):24-7. doi: 10.1016/j.ijoa.2005.04.016. Epub 2005 Oct 26.

  PMID: 16256340 RESULT

• Moore C, Dobson A, Kinagi M, Dillon B. Comparison of blood pressure measured at the arm, ankle and calf. Anaesthesia. 2008 Dec;63(12):1327-31. doi: 10.1111/j.1365-2044.2008.05633.x.

  PMID: 19032301 RESULT

• Lakhal K, Macq C, Ehrmann S, Boulain T, Capdevila X. Noninvasive monitoring of blood pressure in the critically ill: reliability according to the cuff site (arm, thigh, or ankle). Crit Care Med. 2012 Apr;40(4):1207-13. doi: 10.1097/CCM.0b013e31823dae42.

  PMID: 22425818 RESULT

Study Officials

• Steven Lagadec, RN

  Centre Hospitalier Sud Francilien

  STUDY DIRECTOR

Central Study Contacts

Elodie Henry, CRU manager

CONTACT

+33161693730; elodie.henry@chsf.fr

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

FR (8)