CHU de Nantes
Nantes, 44093, France
NCT Number: NCT06999863
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.
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Notify Me18 year–99 year
All sexes
Observational
Nantes, 44093, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Day 1
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
Time frame: Day 1
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.
Time frame: Day 1
A p-value < 0.05 will be used as the threshold for statistical significance in comparisons.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for each BP component.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for each BP component.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for different BMI ranges.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for varying arm circumferences.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for different classes of ages
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses for different classes of ages.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses according to acute circulatory failure or not.
Time frame: Day 1
The primary evaluation criteria will be applied to subgroup analyses according to the ventilation mode
Nantes University Hospital
Other
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
Acronym: CASBA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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