Blood PressurePERCEPTIONNCT06602089
Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements
An observational study of Blood Pressure, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Arterial pressure monitoring
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2024to 26 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
- Conditions
- Blood Pressure
- Being tested
- Arterial pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial pressure monitoringDevice
We will record intraarterial arterial pressure, finger-sensor arterial pressure and oscillometric arterial pressure in all included patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: During surgery
Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
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.
Measured: During surgery
Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
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.
Measured: During surgery
Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alina Bergholz, University of Hamburg-Eppendorf
- Investigators
- Alina Bergholz, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602089
- Sponsor's protocol ID
- 2024-101274-BO-ff
- Acronym
- PERCEPTION
- Status last verified
- Jun 2025
- First submitted
- 8 Sep 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bergholz A, Wohlert M, Krause L, Thomsen KK, Flick M, Saad R, Wegge M, Breitfeld P, Kouz K, Saugel B. Finger-cuff and oscillometric versus intra-arterial blood pressure measurements: a prospective method comparison study in patients having noncardiac surgery. Br J Anaesth. 2026 Jul 20:S0007-0912(26)00421-6. doi: 10.1016/j.bja.2026.05.022. Online ahead of print.
PubMed 42476889
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements: a Method Comparison in Patients Having Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06602089
- Acronym / sponsor ID
- PERCEPTION / 2024-101274-BO-ff
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial pressure monitoringWe will record intraarterial arterial pressure, finger-sensor arterial pressure and oscillometric arterial pressure in all included patients. | Device | – |
Primary outcome
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.
4 secondary outcomes
Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
Time frame: During surgery
Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
Time frame: During surgery
Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
Time frame: During surgery
Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42476889Bergholz A, Wohlert M, Krause L, Thomsen KK, Flick M, Saad R, Wegge M, Breitfeld P, Kouz K, Saugel B. Finger-cuff and oscillometric versus intra-arterial blood pressure measurements: a prospective method comparison study in patients having noncardiac surgery. Br J Anaesth. 2026 Jul 20:S0007-0912(26)00421-6. doi: 10.1016/j.bja.2026.05.022. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alina Bergholz, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University of Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06602089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.