Intraoperative Hypotension
Conditions
Brief summary
A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.
Interventions
Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age ≥ 20 years; * Scheduled liver transplantation * Planned pressure monitoring with an arterial line; * General anesthesia
Exclusion criteria
* Contraindication for invasive blood pressure monitoring * End-staged renal disease * pre-operative MAP \<65 mmHg * Severe heart failure * Severe cardiac shunt * Severe aortic stenosis * Severe atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accurate hypotension prediction of EV1000 system | MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day. | Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min |
| Incidence of intraoperative hypotension | MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day | Frequency, duration of intraoperative hypotension, which defined as MAP \< 65 mmHg at least 1 min |
| Severity of intraoperative hypotension | MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day | MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) \< 65 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay and ICU stay | Days from admission to discharge, assessed up to 1 month | The incidence and severity of intraoperative hypotension correlate with patient's hospital stay and ICU stay |
| Mortality after surgery | Days from admission to discharge, assessed up to 1 month | The incidence and severity of intraoperative hypotension correlate with patient's mortality |
| Adverse effects | Days from admission to discharge, assessed up to 1 month | The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury |
Countries
Taiwan
Contacts
Primary ContactBO HAN YEH
Outcome results
None listed