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Starting soon Not applicable

Hypotension Prediction Index and Intraoperative Hypotension Incidence

NCT06909786 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-04-04

Condition(s) studied

Intraoperative Hypotension

Investigational drug(s) / intervention(s)

HPI guided hemodynamic managementstandard arterial line

HPI guided hemodynamic management: BP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to the HPI (Edwards Lifesciences). The treating anesthetist is trained to understand Acumen IQ parameters and the meaning of HPI, MAP, CI, SVI, SVR, SVV, Eadyn, dP/dtmax. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and how to treat hypotension. The hemodynamic management is performed according to the HPI guided algorithm.

standard arterial line: BP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to TruWave DPT and run data via HemoSphere machine (Edwards Lifesciences). The target of intraoperative blood pressure was to maintain MAP \> 65mmHg. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.

Study summary

This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the use of this algorithm will alter treatment of hypotension and reduces the amount of hypotension as measured by the time weighted average (TWA) during non-cardiac surgery and to anticipate a reduction of postoperative AKI incidents, to explore the clinical benefits of impact of Acumen guided algorithm hemodynamic management in postoperative intestinal function recovery, and postoperative cardiac complications.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age\> 60 years old * Frail score \> 2 * ASA≥2 * Planned to receive general anesthesia * Elective laparoscopic or laparotomy major abdominal surgery with an expected duration of \> 180 minutes * Planned to receive an arterial line monitoring intraoperatively * Being able to give written informed consent prior to surgery Exclusion Criteria: * Severe cardiac arrhythmia including atrial fibrillation * Severe aortic stenosis * Uncontrolled Hypertension (sitting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening) * Significant hypotension before surgery defined as a MAP \<65mmHg * Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease * Organ transplant surgery, surgery involving the kidney, liver surgery requiring hilar blockage, surgery requiring controlled hypotension or controlled low central venous pressure

Primary outcome measure(s)

  • The occurrence of intraoperative hypotension — From anesthesia to end of operation, assessed up to 8 hours.
    Definition of intraoperative hypotension: MAP\< 65mmHg lasting for\> 1 minute. The occurrence of intraoperative hypotension: number of hypotension events, area under the hypotension curve, time-weighted average hypotension, total cumulative time of hypotension, ratio of cumulative total time of hypotension to length of operation

Trial sites (1)

FacilityCityRegionStatus
the First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06909786 on ClinicalTrials.gov ↗ ← All trials in China