Non-invasive prediction of low blood pressure during surgery
Official title: Prospective Interventional Study Investigating a Goal-directed Therapy Based on Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Hypotension in Patients Undergoing Major Orthopedic and Trauma Surgery
Run by University of Giessen · NCT06291714 · Data updated 2026-11-12
This study tests a new tool that helps doctors predict low blood pressure during long surgeries to keep patients safer and reduce complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Giessen Academic / other |
| Locations | 1 site (Giessen) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | March 31, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT06291714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 45 years and older undergoing major trauma or orthopedic surgeries in a supine position.
✕Probably not a fit
Patients who are undergoing surgeries with planned invasive blood pressure monitoring or those with certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to reduce intraoperative hypotension (IOH) by utilizing a non-invasive monitoring tool called the Hypotension Prediction Index (HPI). The HPI predicts the onset of IOH up to 15 minutes in advance by analyzing blood pressure data through a machine learning algorithm. The study focuses on patients undergoing major trauma or orthopedic surgeries while under general anesthesia for more than 90 minutes. By implementing goal-directed therapy based on continuous monitoring, the study seeks to minimize complications such as acute kidney injury and myocardial injury after non-cardiac surgery.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of intraoperative hypotension and its associated complications.
How similar studies have gone: Other studies have shown success with similar non-invasive monitoring approaches, indicating potential for this method to be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients undergoing major trauma or orthopedic surgery in supine position, which is defined as:
* Reconstructive Surgery of the pelvis (e.g., stabilization of fractures)
* Total hip arthroplasty
* Surgery of the proximal femur (e.g., stabilization of fractures)
* Total knee arthroplasty
* Surgery of the spine
* Performance of general anesthesia with planned duration of \>90min
* Age ≥ 45 years
Exclusion Criteria:
\- Predefined exclusion criteria are:
* Planned invasive blood pressure monitoring
* Participation in another interventional study
* Pregnancy and nursing mothers
* Surgery without controlled mechanical ventilation
* ASA I or IV
* Arterial Fibrillation
* Allergy against gelantine
Where it's running
-
Justus-Liebig-University of Giessen
Giessen, Germany Recruiting
Study contacts
- Principal investigator: Michael Sander, Prof. — Justus-Liebig-University of Giessen
- Study coordinator: Emmanuel Schneck, M.D.
- Email: emmanuel.schneck@chiru.med.uni-giessen.de
- Phone: 0049 641 985 44401
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Managing blood pressure to prevent kidney injury after heart surgery
This study tests if managing blood pressure more carefully during heart surgery can help prevent kidney problems afterwards.
-
Remote Ischemic Preconditioning at Different Times After Heart Valve Surgery
This study tests whether applying brief, controlled blood-flow restrictions to a limb at different times after heart valve surgery can help protect organs and reduce complications like kidney injury.
-
Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes
This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.
-
Biomarkers to predict CSA-AKI risk before heart surgery
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Remimazolam vs propofol for stable blood pressure during thoracic/abdominal endovascular aortic repair
This trial tests whether remimazolam keeps blood pressure steadier than propofol during TEVAR or EVAR in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.