The Global Hypoperfusion Index (GHI) Algorithm is designed to assist clinicians in predicting a patient’s likelihood of experiencing a global hypoperfusion event. A global hypoperfusion event is defined as a scenario where mixed venous oxygen saturation (SvO2) drops to 60% or below for at least one minute. This algorithm makes predictions on average 10-15 minutes before such an event occurs. The algorithm is intended for surgical and non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.
Global Hypoperfusion Index (GHI) Algorithm Use
The GHI Algorithm is intended for use in a critical care environment by qualified personnel or trained clinicians in a hospital setting. It aids in predicting a patient’s risk of hemodynamic instability. This algorithm is designed to be used adjunctively, not as a sole basis for therapeutic decisions.
The algorithm generates an index ranging from 0 to 100. A higher value indicates a higher likelihood of a global hypoperfusion event occurring. This prediction uses a machine-learning model based on real-time patient health data. When the patient’s risk reaches a predefined threshold, the algorithm alerts the clinician, allowing them time for appropriate clinical review and action.
Edwards Lifesciences, LLC developed this algorithm. They received FDA premarket notification for the Global Hypoperfusion Index (GHI) Algorithm on July 26, 2023.
References
https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231038.pdf
You must be logged in to post a comment.