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

Launched by UNIVERSITY OF GIESSEN · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor blood pressure during major surgeries to help prevent a condition called intraoperative hypotension (IOH), which is when blood pressure drops too low during surgery. The researchers want to see if using a special non-invasive system called ClearSight, which continuously tracks blood pressure without needing any needles, can reduce the risk of IOH, as well as other complications like kidney injury and heart issues after surgery. This method aims to predict drops in blood pressure up to 15 minutes in advance, potentially allowing for timely interventions to keep patients safe.

To be eligible for this study, participants must be 45 years or older and scheduled for specific major surgeries, such as hip or knee replacements, or spine surgery, with a planned duration of over 90 minutes. The study does not allow participants who are already receiving invasive blood pressure monitoring or who have certain medical conditions. If you choose to participate, you can expect to be monitored closely throughout your surgery using this innovative technology, and your experience may contribute to better outcomes for future patients.

Gender

ALL

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