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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.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether the non-invasive SBP and DBP 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of a surgical intensive care unit having an arterial catheter
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| Name | Affiliation | Role |
|---|---|---|
| Karim LAKHAL, PH | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
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| Day 1 |
| To perform statistical comparisons of measurement errors based on sleeve presence, sleeve thickness, and reference algorithm. | A p-value < 0.05 will be used as the threshold for statistical significance in comparisons. | Day 1 |
| To assess the risk associated with measurement errors for each condition. | Via a dedicated error grid, the risk associated with measurement errors was classified into one of the 5 risk levels ranging from "no risk" to "dangerous risk". Distribution across the different risk levels was compared by Fisher exact tests. | 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). | The ability of averaged noninvasive measurements to detect hypotension (invasive MBP <65 mmHg, SBP <90 mmHg), hypertension (invasive MBP>100 mmHg, SBP >140 mmHg), and a significant therapy-induced change in invasive MBP (>10%) was determined through area under the receiver operating characteristic curve (AUCROC) analysis. | Day 1 |
| To evaluate variability in cuff measurements within a given condition. | Measurement variability will be assessed using the coefficient of variation. The clinical performance of an average of multiple measurements will also be compared to that of a single measurement. | Day 1 |
| Analysis of subgroup differences based on BP levels (above vs. below median values). | The primary evaluation criteria will be applied to subgroup analyses for each BP component. | Day 1 |
| Analysis of subgroup differences based on measurement error levels (above vs. below median values) | The primary evaluation criteria will be applied to subgroup analyses for each BP component. | Day 1 |
| Analysis of subgroup differences based on BMI (above vs. below median and above vs. below 30 kg/m²) | The primary evaluation criteria will be applied to subgroup analyses for different BMI ranges. | Day 1 |
| Analysis of subgroup differences based on arm circumference (above vs. below median) | The primary evaluation criteria will be applied to subgroup analyses for varying arm circumferences. | Day 1 |
| Analysis of subgroup differences based on age (above vs. below 60 years) | The primary evaluation criteria will be applied to subgroup analyses for different classes of ages | Day 1 |
| Analysis of subgroup differences based on age (above vs. below 60 years) | The primary evaluation criteria will be applied to subgroup analyses for different classes of ages. | Day 1 |
| Analysis of subgroup differences based on presence of acute circulatory failure or not | The primary evaluation criteria will be applied to subgroup analyses according to acute circulatory failure or not. | Day 1 |
| Analysis of subgroup differences based on ventilation mode (mechanical vs. non-mechanical) | The primary evaluation criteria will be applied to subgroup analyses according to the ventilation mode | Day 1 |