Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLCThe Global Hypoperfusion Index (GHI) Algorithm is a software tool used on compatible advanced monitoring platforms to predict the risk of a global hypoperfusion event in surgical or non-surgical patients. It analyzes physiological data to provide clinicians with early warning of potential hemodynamic instability, helping to anticipate and manage patient deterioration in critical care settings.
Intended Use
The Global Hypoperfusion Index (GHI) software feature provides physiological insight into a patient's likelihood of a global hypoperfusion event occurring in the next 10-15 minutes in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.
Technology
The GHI algorithm uses a machine learning predictive model that analyzes real-time physiological data inputs from advanced hemodynamic monitoring devices, including Swan-Ganz catheters, calculating an index score from 0 to 100 indicating the risk of a global hypoperfusion event. It alerts clinicians 10-15 minutes before the physiological event occurs to enable timely intervention.
Performance
The device underwent algorithm verification and validation using retrospective clinical data from multiple independent datasets of adult patients undergoing surgical procedures with invasive monitoring. It passed all safety and performance tests, demonstrating substantial equivalence to predicate devices with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/12/2023
3 months - 2
FDA Approval
7/26/2023
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