NCT06291714 Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension
| NCT ID | NCT06291714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Giessen |
| Condition | Intraoperative Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-08-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Michael Sander, Prof.
PRINCIPAL INVESTIGATOR
Justus-Liebig-University of Giessen
Frequently Asked Questions
Who can join the NCT06291714 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Intraoperative Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06291714 currently recruiting?
Yes, NCT06291714 is actively recruiting participants. Contact the research team at emmanuel.schneck@chiru.med.uni-giessen.de for enrollment information.
Where is the NCT06291714 trial being conducted?
This trial is being conducted at Giessen, Germany.
Who is sponsoring the NCT06291714 clinical trial?
NCT06291714 is sponsored by University of Giessen. The principal investigator is Michael Sander, Prof. at Justus-Liebig-University of Giessen. The trial plans to enroll 150 participants.