Blood PressureCUFF-SITENCT07078045
Oscillometric Arterial Pressure Measurements at Different Limb Sites
An observational study of Blood Pressure, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This prospective, single-center observational study aims to evaluate the measurement performance of oscillometric arterial pressure measurements at different limb sites. Specifically, oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg with intraarterial arterial… 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
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jul 2025to 15 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: The CUFF-SITE study is a single-center prospective method comparison study conducted at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. A total of 84 patients scheduled for non-cardiac surgery with general anesthesia in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned will be included.
Who may be able to join
- Consenting patients ≥18 years scheduled for elective non-cardiac surgery with general anesthesia
- Patients in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned
Who cannot join
- Patients with systolic arterial pressure interarm differences >20 mmHg
- Patients with severe peripheral arterial disease
- Patients with heart rhythms other than sinus rhythm
- Patients with contraindications for peripheral cuff placement (e.g., arteriovenous fistula, skin lesions)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oscillometric Arterial Pressure Measurements at Different Limb Sites: the CUFF-SITE Method Comparison Study
This prospective, single-center observational study aims to evaluate the measurement performance of oscillometric arterial pressure measurements at different limb sites. Specifically, oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg with intraarterial arterial pressure measurements will be compared in non-cardiac surgery patients.
The results will provide insight into the reliability and accuracy of oscillometric blood pressure readings at alternative limb sites in clinical practice.
- 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 monitoringOther
We will perform oscillometric arterial pressure measurements at different limb sites.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative patients with intraarterial arterial catheter | Not described Receives: Other: Arterial pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between oscillometric and intraarterial arterial pressure measurements
Mean ± standard deviation of the differences with 95% limits of agreement between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure).
Measured: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Secondary outcomes (4)
Correlation coefficients
Correlation coefficients between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure).
Measured: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Classification of measurement differences
Classification of measurement differences between oscillometric arterial pressure monitoring at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure monitoring according to their clinical relevance (for mean and systolic arterial pressure)
Measured: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Percentage of oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg that are within ±5 mmHg of the corresponding intraarterial arterial pressure measurements
Percentage of oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg that are within ±5 mmHg of the corresponding intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure)
Measured: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Cross-comparisons
Mean ± standard deviation of the differences with 95% limits of agreement between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg (for mean, systolic, and diastolic arterial pressure)
Measured: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start28 Jul 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 84 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, University Medical Centre Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078045
- Sponsor's protocol ID
- 2025-101519-BO-ff
- Other IDs
- 2025
- Acronym
- CUFF-SITE
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillometric Arterial Pressure Measurements at Different Limb Sites: the CUFF-SITE Method Comparison Study
- ClinicalTrials.gov ID
- NCT07078045
- Acronym / sponsor ID
- CUFF-SITE / 2025-101519-BO-ff
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 22 Jul 2025 (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 prospective, single-center observational study aims to evaluate the measurement performance of oscillometric arterial pressure measurements at different limb sites. Specifically, oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg with intraarterial arterial pressure measurements will be compared in non-cardiac surgery patients.
The results will provide insight into the reliability and accuracy of oscillometric blood pressure readings at alternative limb sites in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative patients with intraarterial arterial catheter | – | Other: Arterial pressure monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CUFF-SITE study is a single-center prospective method comparison study conducted at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. A total of 84 patients scheduled for non-cardiac surgery with general anesthesia in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned will be included.
Key inclusion criteria (2 listed)
- Consenting patients ≥18 years scheduled for elective non-cardiac surgery with general anesthesia
- Patients in whom intraarterial arterial pressure monitoring with a radial artery catheter is planned
Key exclusion criteria (5 listed)
- Patients with systolic arterial pressure interarm differences >20 mmHg
- Patients with severe peripheral arterial disease
- Patients with heart rhythms other than sinus rhythm
- Patients with contraindications for peripheral cuff placement (e.g., arteriovenous fistula, skin lesions)
- Pregnant women
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 perform oscillometric arterial pressure measurements at different limb sites. | Other | Postoperative patients with intraarterial arterial catheter |
Primary outcome
Agreement between oscillometric and intraarterial arterial pressure measurements
Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Mean ± standard deviation of the differences with 95% limits of agreement between oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg and intraarterial arterial pressure measurements (for mean, systolic, and diastolic arterial pressure).
4 secondary outcomes
Correlation coefficients
Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Classification of measurement differences
Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Percentage of oscillometric arterial pressure measurements obtained at the upper arm, forearm, thigh, and lower leg that are within ±5 mmHg of the corresponding intraarterial arterial pressure measurements
Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
Cross-comparisons
Time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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
University Medical Centre 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 2 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 9 Sep 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?
Agreement between oscillometric and intraarterial arterial pressure measurements (time frame: Immediate postoperative period, typically within a few hours after surgery (and in all cases within the first 24 postoperative hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.