Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy (PROST-BP)

January 30, 2026 updated by: Dr. Alina Bergholz, University of Hamburg-Eppendorf

Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial

The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bernd Saugel

Study Contact Backup

Study Locations

  • Germany
    • Hamburg
      • Hamburg, Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • male patient ≥18 years
  • scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
  • planned intraarterial blood pressure monitoring

Exclusion Criteria:

  • patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
  • patients participating in another interventional trial likely to influence intraoperative blood pressure management

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oscillometric blood pressure monitoring
Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring.
Other: Oscillometric blood pressure monitoring
In patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals.
Active Comparator: Intraarterial blood pressure monitoring
Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring.
Other: Intraarterial blood pressure monitoring
In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-weighted average MAP <65 mmHg
Time Frame: From the start of surgery until the end of surgery
Time-weighted average MAP <65 mmHg [mmHg], calculated from the start of surgery until the end of surgery (continuous endpoint)
From the start of surgery until the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under a MAP <65 mmHg
Time Frame: From the start of surgery until the end of surgery
Area under a MAP <65 mmHg [mmHg min] (continuous endpoint)
From the start of surgery until the end of surgery
Total duration of MAP <65 mmHg
Time Frame: From the start of surgery until the end of surgery
Total duration of MAP <65 mmHg [min] (continuous endpoint)
From the start of surgery until the end of surgery
Number of discrete hypotensive episodes
Time Frame: From the start of surgery until the end of surgery
Number of discrete hypotensive episodes, defined as MAP <65 mmHg sustained for >1 min (count endpoint)
From the start of surgery until the end of surgery
Area above a MAP >100 mmHg
Time Frame: From the start of surgery until the end of surgery
Area above a MAP >100 mmHg [mmHg min] (continuous endpoint)
From the start of surgery until the end of surgery
Time-weighted average MAP >100 mmHg
Time Frame: From the start of surgery until the end of surgery
Time-weighted average MAP >100 mmHg [mmHg], calculated from randomization until the end of surgery (continuous endpoint)
From the start of surgery until the end of surgery
Average norepinephrine infusion rate
Time Frame: From the start of surgery until the end of surgery
Average norepinephrine infusion rate [μg kg-1 min-1] (continuous endpoint)
From the start of surgery until the end of surgery
Total volume of administered crystalloids
Time Frame: From the start of surgery until the end of surgery
Total volume of administered crystalloids [ml] (continuous endpoint)
From the start of surgery until the end of surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of a composite binary outcome defined as the occurrence of at least one of the following: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death
Time Frame: Within the first 30 postoperative days
Incidence of a composite binary outcome defined as the occurrence of at least one of the following within the first 30 postoperative days: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death (binary endpoint)
Within the first 30 postoperative days
Incidence of need for renal replacement therapy
Time Frame: Within the first 30 postoperative days
Incidence of need for renal replacement therapy within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
Incidence of myocardial infarction
Time Frame: Within the first 30 postoperative days
Incidence of myocardial infarction within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
Incidence of non-fatal cardiac arrest
Time Frame: Within the first 30 postoperative days
Incidence of non-fatal cardiac arrest within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
Incidence of death
Time Frame: Within the first 30 postoperative days
Incidence of death within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
Incidence of postoperative acute kidney injury
Time Frame: Within the first 7 postoperative days
Incidence of postoperative acute kidney injury within the first 7 postoperative days (binary endpoint)
Within the first 7 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-101598-BOff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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