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

NCT06999863 | Completed

• 1 other identifier: RC25_0025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intensive Care Units

Keywords

Blood pressure determination (MeSH); Bare arm; Sleeve; Measurement algorithm; Catheterization, peripheral arterial (MeSH); Cuff; Oscillometry (MeSH)

Outcome Measures

Primary Outcomes (1)

• To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve

  The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg. The reference BP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one

  Day 1

Secondary Outcomes (13)

• To assess whether the non-invasive SBP and DBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve

  Day 1

• To perform statistical comparisons of measurement errors based on sleeve presence, sleeve thickness, and reference algorithm.

  Day 1

• To assess the risk associated with measurement errors for each condition.

  Day 1

• To compare the ability of non-invasive measurements to detect hypotension (MBP or SBP <65 mmHg or <90 mmHg, respectively) and hypertension (MBP or SBP >90 mmHg or >140 mmHg, respectively).

  Day 1

• To evaluate variability in cuff measurements within a given condition.

  Day 1

Interventions

Patients of a surgical intensive care unit OTHER

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).

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of a surgical intensive care unit having an arterial catheter

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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.
• Absence of social security coverage.
• Non-French speaker patient (i.e. unable to receive study information)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Study Officials

• Karim LAKHAL, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 31, 2025
• Study Start: July 24, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)