EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
DeviceEV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
NCT Number: NCT03805217
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
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Notify Me18 year and older
All sexes
Observational
Stanford Health Care, Stanford, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
Time frame: Duration of Surgery
Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
Time frame: Duration of Surgery
The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.
Edwards Lifesciences
Industry
Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
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