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Oscillometric Arterial Pressure Measurements at Different Limb Sites

Oscillometric Arterial Pressure Measurements at Different Limb Sites: the CUFF-SITE Method Comparison Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07078045
Acronym
CUFF-SITE
Enrollment
84
Registered
2025-07-22
Start date
2025-07-28
Completion date
2025-12-15
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

This prospective, single-center observational study aims to evaluate the measurement performance of oscillometric arterial pressure measurements at different limb sites. Specifically, oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg with intraarterial arterial pressure measurements will be compared in non-cardiac surgery patients. The results will provide insight into the reliability and accuracy of oscillometric blood pressure readings at alternative limb sites in clinical practice.

Interventions

We will perform oscillometric arterial pressure measurements at different limb sites.

Sponsors

University of Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consenting patients ≥18 years scheduled for elective non-cardiac surgery with general anesthesia * Patients in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned

Exclusion criteria

* Patients with systolic arterial pressure interarm differences \>20 mmHg * Patients with severe peripheral arterial disease * Patients with heart rhythms other than sinus rhythm * Patients with contraindications for peripheral cuff placement (e.g., arteriovenous fistula, skin lesions) * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Agreement between oscillometric and intraarterial arterial pressure measurementsImmediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)Mean ± standard deviation of the differences with 95% limits of agreement between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure).

Secondary

MeasureTime frameDescription
Correlation coefficientsImmediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)Correlation coefficients between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure).
Classification of measurement differencesImmediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)Classification of measurement differences between oscillometric arterial pressure monitoring at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure monitoring according to their clinical relevance (for mean and systolic arterial pressure)
Percentage of oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg that are within ±5 mmHg of the corresponding intraarterial arterial pressure measurementsImmediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)Percentage of oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg that are within ±5 mmHg of the corresponding intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure)
Cross-comparisonsImmediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)Mean ± standard deviation of the differences with 95% limits of agreement between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg (for mean, systolic, and diastolic arterial pressure)

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORAlina Bergholz, MD

University Medical Centre Hamburg-Eppendorf

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026