Blood Pressure MonitoringAGREE-BPNCT07870356
Measurement Agreement Between IBP and NIBP During Induction of Anesthesia in High Risk Patients
An observational study of Blood Pressure Monitoring, run by Medical University of Graz at 1 site in Austria.
Trial summary
The AGREE-BP study aims to evaluate how closely blood pressure measurements taken with an automated upper-arm cuff agree with measurements taken through a small plastic tube placed in an artery, called an arterial catheter, during the start of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure Monitoring
- What is being tested?
- non-invasive oscillometric blood pressure monitoring
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 7 Oct 2026to Oct 2027
- Phase
- Observational
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: Adults patients with a high-risk of hemodynamic changes during induction of anesthesia undergoing general anesthesia induction with clinically indicated intraarterial blood pressure monitoring before induction.
Who may be able to join
- Intraarterial blood pressure monitoring prior to induction of anesthesia is necessary for clinical reasons
- Surgery under general anesthesia
- Provision of written informed consent
- Less than a 5 mmHg difference between consecutive non-invasive oscillometric blood pressure measurements on the left and right arms
- Supine positioning during induction of anesthesia possible and used for clinical reasons.
- At least one of the following factors indicating high-risk of blood pressure changes during induction of anesthesia:
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- Peripheral arterial disease
- Carotid artery disease
- Severe coronary artery disease
- Arterial hypertension requiring three or more antihypertensive agents
Who cannot join
- Inability to insert the intraarterial catheter and venous catheter on the same arm (mandatory to be on the contralateral side of the non-invasive oscillometric measurement)
- Pregnancy
- Planned awake fiberoptic intubation
- Previous enrollment in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Department of Anaesthesiology and Intensive Care Medicine
Graz, Styria, 8010
Michael Eichlseder, MD PhD, +43 316 385 81919, michael.eichlseder@medunigraz.at
Nikolaus Schreiber, MD PhD, +43 316 385 81917
About this study
Official title: Measurement Agreement Between Intraarterial (IBP) and Intermittent Non-Invasive Blood Pressure (NIBP) Monitoring During Induction of Anesthesia in High Risk Patients: The AGREE-BP Prospective Observational Study
The AGREE-BP study aims to evaluate how closely blood pressure measurements taken with an automated upper-arm cuff agree with measurements taken through a small plastic tube placed in an artery, called an arterial catheter, during the start of general anesthesia.
Blood pressure can change rapidly when patients receive medication to induce general anesthesia. These changes may be particularly pronounced in patients with heart or blood vessel disease or high blood pressure. An upper-arm cuff measures blood pressure at intervals, whereas an arterial catheter measures it continuously with each heartbeat. Although cuff measurements are widely used, their agreement with arterial catheter measurements during this period of rapid change is not fully evaluated and validated.
Read more
This observational study will include 120 patients undergoing surgery under general anesthesia at University Hospital Graz, Austria. Participants will have conditions that increase their risk of blood pressure changes and will already require an arterial catheter before anesthesia for medical reasons.
During the first five minutes after administration of the medication used to induce anesthesia, researchers will record blood pressure using both methods. The cuff will be placed on the arm opposite the arterial catheter and will take measurements at least once per minute, or more frequently if the monitor allows. Anesthesia and treatment decisions will remain the responsibility of the treating clinician. Participation does not require additional follow-up visits.
The main aim is to assess agreement in mean arterial pressure, which is the average pressure in the arteries over a heartbeat. Researchers will also compare systolic pressure, the pressure when the heart contracts, and diastolic pressure, the pressure when the heart relaxes. They will examine whether patient characteristics or treatments are associated with differences between the two measurement methods and will separately assess agreement during particularly large, rapid blood pressure changes.
The findings may help clinicians understand when cuff measurements differ meaningfully from arterial catheter measurements and inform future decisions about blood pressure monitoring during the start of anesthesia.
- Conditions
- Blood Pressure Monitoring
- Being tested
- non-invasive oscillometric blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive oscillometric blood pressure monitoringOther
Also called NIBP
In addition to intraarterial blood pressure monitoring, non-invasive oscillometric blood pressure monitoring will be performed on the contralateral arm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure measurement Agreement between IBP and NIBP
Measurement agreement in mean arterial pressure between intraarterial (reference test) and intermittent non-invasive oscillometric (index test) blood pressure monitoring in high-risk patients having induction of anesthesia.
Measured: In the first five minutes after induction of anesthesia.
Secondary outcomes (3)
Diastolic arterial pressure measurement agreement between IBP and NIBP
Measurement agreement of diastolic arterial pressure between intraarterial (reference test) and intermittent non-invasive oscillometric (index test) blood pressure monitoring in high-risk patients having induction of anesthesia.
Measured: In the first five minutes after induction of anesthesia.
Systolic arterial pressure measurement Agreement between IBP and NIBP
Measurement agreement of systolic arterial pressure between intraarterial (reference test) and intermittent non-invasive oscillometric (index test) blood pressure monitoring in high-risk patients having induction of anesthesia.
Time Frame: In the first five minutes after induction of anesthesia
Measured: In the first five minutes after induction of anesthesia.
Characteristics associated with disagreement between IBP and NIBP
Patient and/or treatment characteristics associated with pairwise disagreement (>10 mmHg) between intraarterial (clinical reference) and intermittent non-invasive oscillometric (index test) blood pressure monitoring in high-risk patients having induction of anesthesia.
Measured: In the first five minutes after induction of anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Oct 2026
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MonitoringStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Eichlseder, MD PhD, Principal investigator, Medical University of Graz, Department of Anaesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870356
- Sponsor's protocol ID
- EK1288/2026
- Acronym
- AGREE-BP
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on reasonable request.