Skip to main content
OpenTrials
Completed

NCT Number: NCT07078045

Oscillometric Arterial Pressure Measurements at Different Limb Sites

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial pressure monitoring

Other

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

Primary outcomes

  1. Agreement between oscillometric and intraarterial arterial pressure measurements

    Time frame: Immediate 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 outcomes

  1. Correlation coefficients

    Time frame: Immediate 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).

  2. Classification of measurement differences

    Time frame: Immediate 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)

  3. 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

    Time frame: Immediate 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)

  4. Cross-comparisons

    Time frame: Immediate 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)

Other outcomes

  1. Incidence of measurement failures

    Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)

    Incidence of measurement failures of oscillometric arterial pressure monitoring at the upper arm, forearm, thigh, and lower leg defined as any instance in which the device fails to display an arterial pressure reading or shows an error message

Sponsors and collaborators

Lead sponsor

University of Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: CUFF-SITE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jan 9, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.