Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements (PERCEPTION)
Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements: a Method Comparison in Patients Having Non-cardiac Surgery
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Alina Bergholz, MD
- Phone Number: +4940 7410 0
- Email: a.bergholz@uke.de
Study Contact Backup
- Name: Bernd Saugel, MD
- Phone Number: +4940 7410 0
- Email: b.saugel@uke.de
Study Locations
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Hamburg, Germany, 20246
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥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
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)
- surgery in non-supine positions
- pregnant patients.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: During surgery
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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.
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During surgery
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
Time Frame: During surgery
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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.
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During surgery
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Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
Time Frame: During surgery
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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.
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During surgery
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Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
Time Frame: During surgery
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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.
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During surgery
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Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
Time Frame: During surgery
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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.
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During surgery
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alina Bergholz, MD, Universitätsklinikum Hamburg-Eppendorf
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 2024-101274-BO-ff
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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