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

Condition(s) studied

Investigational drug(s) / intervention(s)

GDT-based hemodynamic management based on Clearsight device: Intraoperative use of a HPI-guided hemodynamic goal-directed protocol based on the non-invasive measurement of HPI (Clearsight system)

Study 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

Primary outcome measure(s)

• Change of the frequency of intraoperative hypotension — through study completion, an average of 1 year
  Change of the frequency of intraoperative hypotension (defined as MAP below 65mmHg, frequency ((n)/h)
• Change of the absolute duration of of intraoperative hypotension — through study completion, an average of 1 year
  Change of the absolute duration of intraoperative hypotension (defined as MAP below 65mmHg, unit: minutes)
• Change of the relative duration of intraoperative hypotension — through study completion, an average of 1 year
  Change of the relative duration of intraoperative hypotension (defined as MAP below 65mmHg, unit: percentage of total anesthesia time)

Trial sites (1)

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