Non-invasive prediction of low blood pressure during surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Locations | 1 site (Giessen) |
| Trial ID | NCT06291714 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45 years and older undergoing major trauma or orthopedic surgeries in a supine position.
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.
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 performed: Other studies have shown success with similar non-invasive monitoring approaches, indicating potential for this method to be effective.
Eligibility criteria
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 this trial is running
Giessen
- 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
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.