RecruitingNCT06999863

Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm

Measurements of Arterial Blood Pressure With an Automated Oscillometric Cuff: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm. A Prospective Observational Single-center Study With an Invasive Reference

Sponsor

Nantes University Hospital

Enrollment

75 participants

Start Date

Jul 24, 2025

Study Type

OBSERVATIONAL

Conditions

Intensive Care Units

Summary

For accurate measurements of arterial blood pressure (BP), international guidelines recommend placing the automated oscillometric cuff directly on the bare upper arm. However, for various reasons, cuffs are often applied over a layer of textile. Whether this practice affects the reliability of the readings remains uncertain. Using a rigorous methodology, the CASBA study aims at addressing this issue. Additionally, two different BP measurement algorithms are available in some oscillometric monitors. To our knowledge, no study has compared the performance of these two algorithms. This study will help determine which oscillometric algorithm should be given priority in intensive care facilities.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

\- Patients having a catheter in the radial artery.
and with stable BP over a 5-min period (no change in invasive MBP \>10% and no change in vasoactive drugs)

Exclusion Criteria11

\- Cardiac arrhythmia.
Dysfunctional of the arterial catheter or waveform, suggesting signal over- or under-damping.
Arm circumference \> 42 cm (measured at mid-arm).
Contraindication to BP measurement on the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access on the limb preventing cuff inflation, other).
Patient's health status requiring urgent care incompatible with study protocol.
Asymmetry of MBP between the two arms (\>5 mmHg) or inability to check it.
Pregnant woman.
Age \<18 years old.
Adult known to be under guardianship or legal supervision before inclusion.
Absence of social security coverage.
Non-French speaker patient (i.e. unable to receive study information)

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Interventions

OTHERPatients of a surgical intensive care unit

Patients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of BP in 3 situations (thick sleeve, thin sleeve, bare arm) and with 2 algorithms (for bare arm measurement only).