Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements

NCT06602089 | Completed

• 1 other identifier: 2024-101274-BO-ff
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study simultaneously comparing finger-sensor and oscillometric with intra-arterial blood pressure measurements in patients having low- to moderate-risk non-cardiac surgery.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Difference in the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements, and the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements

  To investigate whether the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) is better than the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements, we will perform Bland-Altman analyses.

  During surgery

Secondary Outcomes (4)

• Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance

  During surgery

• Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance

  During surgery

• Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring

  During surgery

• Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring

  During surgery

Interventions

Arterial pressure monitoring DEVICE

We will record intraarterial arterial pressure, finger-sensor arterial pressure and oscillometric arterial pressure in all included patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia in whom intraarterial arterial pressure monitoring is planned

You may qualify if:

• ≥18 years
• scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia
• planned intraarterial arterial pressure monitoring with a radial arterial catheter

You may not qualify if:

• systolic arterial pressure interarm differences \>20 mmHg
• heart rhythms other than sinus rhythm
• contraindications for finger-sensor arterial pressure monitoring (e.g., arteriovenous shunts, Raynaud's disease)
• surgery in non-supine positions
• pregnant patients.

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

• Alina Bergholz, MD

  Universitätsklinikum 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: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: May 1, 2026

Record last verified: 2025-06

Locations

DE (1)