protocolSection identificationModule nctId: NCT06291714, orgStudyIdInfo id: Clearsight, briefTitle: Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension, acronym: Clearsight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, collaborators name: Edwards Lifesciences, descriptionModule briefSummary: 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., conditionsModule conditions: Intraoperative Hypotension, conditions: Acute Kidney Injury, conditions: Myocardial Injury After Non-cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Management of interventional group patients Prior to the surgery the rest cardiac index and contractility (dp/dt) must be quantified. For this purpose, the cardiac index will be measured in the preoperative night by applicating the HPI ClearSight system through a study team member. If the rest cardiac index is not available throughout the night because the patient´s sleep is altered by the measurements, the awake cardiac index will be quantified until the monitoring is stopped for the night sleep of the patient. This mean baseline measurements (CI and dp/dt) will then be the target cardiac index throughout the study algorithm (figure 1). In case no sleep measurement was achievable, the awake measurement will be accounted as baseline value. The perioperative study intervention period starts with the beginning of anesthesia and ends at the end of surgery. Intraoperative mean arterial pressure will be maintained at least at 65 mmHg and cardiac index and dp/dt will be individually, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: All patients are connected to the Clearsight device but the interface is masked in the control group., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: GDT-based hemodynamic management based on Clearsight device, outcomesModule primaryOutcomes measure: Change of the frequency of intraoperative hypotension, primaryOutcomes measure: Change of the absolute duration of of intraoperative hypotension, primaryOutcomes measure: Change of the relative duration of intraoperative hypotension, secondaryOutcomes measure: AKI, secondaryOutcomes measure: MINS, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False