Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension

Recruiting now · Not applicable

Conditions studied: Intraoperative Hypotension, Acute Kidney Injury, Myocardial Injury After Non-cardiac Surgery

In brief

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.

Key facts

Study ID

NCT06291714

Run by

University of Giessen

People needed

150

Starts

2024-08-01

Expected to finish

2026-03-31

Last updated by the study team

2025-04-03

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Justus-Liebig-University of Giessen — Giessen, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.