HPI Index With GDHT in Predicting Hypotension In General Anesthesia Patients
- Conditions
- Hypotension During Surgery
- Interventions
- Device: Flotraq Sensor with EV1000 incorporating the HPI algorithm
- Registration Number
- NCT04803903
- Lead Sponsor
- Attikon Hospital
- Brief Summary
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.
- Detailed Description
The perioperative period is characterized by hemodynamic instability. Intraoperative hypotension (IOH) can be caused by anesthesia drugs, surgical manipulations, hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms. In a retrospective analysis performed at the Cleveland Clinic, the risk for acute kidney injury (AKI) and myocardial injury (MI) increased when mean arterial pressure (MAP) was less than 55 mmHg. Further, even short durations of intraoperative hypotension were associated with AKI and MI. Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure. They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and ΜΙ or ΑΚΙ at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with ΜΙ or ΑΚΙ from those without it. The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure. In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min.
Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse, followed by prompt treatment and, ultimately, reversal of the responsible process. Recently a Hypotension Probability Indicator (HPI) algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. The HPI algorithm can be integrated with a goal-directed hemodynamic treatment (GDHT) to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure. We developed a treatment protocol implementing HPI with GDHT that can be used in general anesthesia patients to guide clinical practice.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Aged 18 years or older
- Planned to receive general anaesthesia > 2h
- Planned to receive an arterial line during surgery
- Aim for MAP of ≥ 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
- Severe cardiac arrhythmias including atrial fibrillation
- Requiring dialysis
- Liver surgery with Pringle maneuver
- Vascular surgery with clamping of the aorta
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HPI + GDHT treatment Flotraq Sensor with EV1000 incorporating the HPI algorithm HPI + GDHT treatment using the FlowTraQ sensor and EV1000 monitor with the HPI algorithm incorporated following our protocol for hemodynamic treatment (fluids, vasopressors and inotropes) administered
- Primary Outcome Measures
Name Time Method TWA hypotension (measured with Flotrac sensor) intraoperative, starting 15 minutes after induction Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min
- Secondary Outcome Measures
Name Time Method Incidence of hypotension (measured with Flotrac sensor) intraoperative, starting 15 minutes after induction Incidence of hypotension, defined as MAP \<65mmHg for ≥1min
Time spent in hypotension (measured with Flotrac sensor) intraoperative, starting 15 minutes after induction Time spent in hypotension, in minutes, defined as MAP \<65mmHg for ≥1min
Treatment choice (drugs/fluids) intraoperative, starting 15 minutes after induction Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Treatment dose (drugs/fluids) intraoperative, starting 15 minutes after induction Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time to treatment (drugs/fluids) intraoperative, starting 15 minutes after induction time to treatment of hypotension, defined as MAP \<65mmHg for ≥1min.
Diagnostic guidance protocol deviations intraoperative, starting 15 minutes after induction Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Postoperative Morbidity postoperative, up to 30 days after surgery or until discharge from the hospital Incidence of complications: cardiac, pulmonary, renal
Postoperative Creatinine levels postoperative, up to 30 days after surgery or until discharge from the hospital Measurement if creatinine levels postoperatively
Mortality postoperative, up to 30 days after surgery Incidence of mortality 30 days after surgery
Trial Locations
- Locations (1)
Attikon University Hospital
🇬🇷Athens, Attika, Greece