Clinical trial NCT06999863: Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intensive Care Units
Keywords: Blood pressure determination (MeSH)
Bare arm
Sleeve
Measurement algorithm
Catheterization, peripheral arterial (MeSH)
Cuff
Oscillometry (MeSH)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of a surgical intensive care unit having an arterial catheter

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.

Detailed description: The automated oscillometric cuff is the predominant non-invasive method for measuring BP. For accurate measurements, international guidelines recommend placing the cuff directly on a bare upper arm. However, for reasons of convenience, hygiene, comfort, cultural or religious practices, or skin reactions, cuffs are often applied over a layer of textile. Some authors suggest this practice does not significantly affect BP readings, while other authors are more cautious or even advise against it. Prior studies are not devoid of limitations. Further research into sleeve effects on BP measurement accuracy is warranted. The present study project employs rigorous methodology and leverages invasive arterial catheters for reliable reference measurements. Additionally, the broad range of BP levels in surgical intensive care units ensures comprehensive data, including mean, systolic, and diastolic BP (MBP, SBP, and DBP).

Additionally, some oscillometric monitors incorporate two reference algorithms for BP measurement:

* Auscultatory Reference Algorithm: Calibrates oscillometric measurements to align with manual cuff and stethoscope values. This is the default setting.
* Invasive Reference Algorithm: Adjusts non-invasive BP values to approximate invasive measurements.

Health care providers are, in our experience, rarely aware of the existence of these two distinct algorithms. Although the reference auscultatory algorithm is generally recommended for routine non-invasive monitoring, such as at home or in a clinic, the invasive reference algorithm might be preferable in critical care settings. Importantly, in the absence of published studies on the subject, these considerations remain speculative.

However, it is important to determine which oscillometric algorithm should be prioritized in critical care settings, where invasive measurement serves as the reference. This will be a secondary objective of this study.

Eligibility criteria: Inclusion Criteria:

* - 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 Criteria:

* - 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)

Primary outcomes:
measure: To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
timeFrame: Day 1
Secondary outcomes:
measure: To assess whether the non-invasive SBP and DBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
timeFrame: Day 1
measure: To perform statistical comparisons of measurement errors based on sleeve presence, sleeve thickness, and reference algorithm.
timeFrame: Day 1
measure: To assess the risk associated with measurement errors for each condition.
timeFrame: Day 1
measure: 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).
timeFrame: Day 1
measure: To evaluate variability in cuff measurements within a given condition.
timeFrame: Day 1
measure: Analysis of subgroup differences based on BP levels (above vs. below median values).
timeFrame: Day 1
measure: Analysis of subgroup differences based on measurement error levels (above vs. below median values)
timeFrame: Day 1
measure: Analysis of subgroup differences based on BMI (above vs. below median and above vs. below 30 kg/m²)
timeFrame: Day 1
measure: Analysis of subgroup differences based on arm circumference (above vs. below median)
timeFrame: Day 1
measure: Analysis of subgroup differences based on age (above vs. below 60 years)
timeFrame: Day 1
measure: Analysis of subgroup differences based on age (above vs. below 60 years)
timeFrame: Day 1
measure: Analysis of subgroup differences based on presence of acute circulatory failure or not
timeFrame: Day 1
measure: Analysis of subgroup differences based on ventilation mode (mechanical vs. non-mechanical)
timeFrame: Day 1
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Karim LAKHAL, PH
role: PRINCIPAL_INVESTIGATOR
References: