Oscillometric Arterial Pressure Measurements at Different Limb Sites

NCT07078045 | Completed

• 1 other identifier: 2025-101549-BO-ff
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Agreement between oscillometric and intraarterial arterial pressure measurements

  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).

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

Secondary Outcomes (4)

• Correlation coefficients

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

• Classification of measurement differences

  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

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

• Cross-comparisons

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

Other Outcomes (1)

• Incidence of measurement failures

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

Study Arms (1)

Postoperative patients with intraarterial arterial catheter

Other: Arterial pressure monitoring

Interventions

Arterial pressure monitoring OTHER

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

Postoperative patients with intraarterial arterial catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CUFF-SITE study is a single-center prospective method comparison study conducted at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. A total of 84 patients scheduled for non-cardiac surgery with general anesthesia in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany, Germany

Location

Study Officials

• Alina Bergholz, MD

  University Medical Centre Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: July 29, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)