Cuff (intermittent) versus arterial-line (continuous) blood pressure monitoring during robot-assisted prostatectomy
Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial
This will test whether regular cuff blood pressure checks work as well as a continuous arterial line to prevent low blood pressure during robot-assisted prostate removal in adult men.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT07349186 on ClinicalTrials.gov |
What this trial studies
PROST-BP is a prospective, single-center, randomized, patient-blinded non-inferiority trial comparing intermittent oscillometric (cuff) blood pressure monitoring with continuous intraarterial monitoring during robot-assisted radical prostatectomy in steep Trendelenburg position. Eligible adult men who are scheduled for planned intraarterial monitoring are randomized to receive either standard arterial-line monitoring or intermittent cuff measurements during surgery. The primary outcome is the occurrence or burden of intraoperative hypotension, with monitoring and management performed according to standardized anesthetic protocols. The trial is conducted at the University Medical Center Hamburg-Eppendorf and enrolls patients who do not require mandatory arterial monitoring for clinical reasons.
Who should consider this trial
Good fit: Adult men (≥18 years) scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg who were planned to have intraarterial blood pressure monitoring but for whom an arterial line is not mandatory are ideal candidates.
Not a fit: Patients who require mandatory arterial-line monitoring for clinical reasons or who are enrolled in another interventional trial affecting blood pressure management are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, patients could avoid an invasive arterial line during this surgery without increasing their risk of intraoperative low blood pressure.
How similar studies have performed: Previous comparisons of noninvasive oscillometric versus invasive arterial monitoring in other surgical settings have shown mixed results, and this specific robot-assisted, steep Trendelenburg setting has been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Alina Bergholz
- Email: a.bergholz@uke.de
- Phone: 004940 7410 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.