Superiority of Finger-sensor Monitoring: a Prospective Observational Study

Not yet recruiting

• Conditions: Blood Pressure

• Registration Number: NCT06602089
• Lead Sponsor: University of Hamburg-Eppendorf

Brief Summary

This is an observational study investigating whether finger-sensor arterial pressure monitoring is superior to oscillometric arterial pressure monitoring in patients having non-cardiac surgery. Specifically, the investigators will test the hypothesis that 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 mean arterial pressure measurements and intraarterial mean arterial pressure measurements in patients having low- to moderate-risk non-cardiac surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-08
• Study Start: 2024-09-09
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 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)
• pregnant patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	During surgery	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.

Secondary Outcome Measures

Name	Time	Method
Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance	During surgery	To classify measurement differences (mean arterial pressure and systolic arterial pressure) between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance, we will perform error grid analyses.
Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance	During surgery	To classify measurement differences (mean arterial pressure and systolic arterial pressure) between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance, we will perform error grid analyses.
Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring	During surgery	To investigate the ability of finger-sensor arterial pressure monitoring to track arterial pressure changes (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) compared to intraarterial arterial pressure monitoring, we will compute four-quadrant plots and calculate the concordance rate.
Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring	During surgery	To investigate the ability of oscillometric arterial pressure monitoring to track arterial pressure changes (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) compared to intraarterial arterial pressure monitoring, we will computer four-quadrant plots and calculate the concordance rate.

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany