- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602089
Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements (PERCEPTION)
April 27, 2026 updated by: Dr. Alina Bergholz, University of Hamburg-Eppendorf
Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements: a Method Comparison in Patients Having Non-cardiac Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
Time Frame: 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.
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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
|
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.
|
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.
|
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
|
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.
|
During surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alina Bergholz, MD, Universitatsklinikum Hamburg-Eppendorf
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2024
Primary Completion (Actual)
June 26, 2025
Study Completion (Actual)
June 26, 2025
Study Registration Dates
First Submitted
September 8, 2024
First Submitted That Met QC Criteria
September 15, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024-101274-BO-ff
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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