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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP\<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible. Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome. Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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 \&gt;90min

∙ Age ≥ 45 years

Locations
Other Locations
Germany
Justus-Liebig-University of Giessen
RECRUITING
Giessen
Contact Information
Primary
Emmanuel Schneck, M.D.
emmanuel.schneck@chiru.med.uni-giessen.de
0049 641 985 44401
Backup
Michael Sander, Prof.
michael.sander@chiru.med.uni-giessen.de
0049 641 985 44401
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Interventional group
GDT-therapy guided hemodynamic management based on Clearsight system
No_intervention: Control group
Clearsight-monitor is blinded but records standard hemodynamic care
Related Therapeutic Areas
Sponsors
Leads: University of Giessen
Collaborators: Edwards Lifesciences

This content was sourced from clinicaltrials.gov