Clinical trial Recruiting at 1 site Interventional Ages 45 and up

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.

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Quick facts

Study typeInterventional
Ages45 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Giessen
Academic / other
Locations1 site (Giessen)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedMarch 31, 2025
Study endsMarch 31, 2026
Registry record updatedApril 3, 2025
Trial IDNCT06291714 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.