About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age> 60 years old
Frail score > 2
ASA≥2
Planned to receive general anesthesia
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
HPI guided hemodynamic management
Procedure/SurgeryBP, 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
Other interventionBP, 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.
Treatment groups
Trial outcomes
Primary outcomes
The occurrence of intraoperative hypotension
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
Secondary outcomes
Incidents of AKI
Definition of AKI according to KDIGO (Kidney Disease Improving Global Outcomes) criteria: elevated serum creatinine more than 0.3 mg/dl within 48 hours or more than 150% of basal value within 7 days, or urine output \< 0.5 ml/kg/hour for more than 6 hours. The stages of AKI will not be divided.
Intestinal peristalsis recovery time
Auscultation every 4 hours after surgery, and the appearance of ≥4 bowel sounds per minute is considered to be intestinal peristalsis recovery.
Intestinal function recovery time
Time from end of operation to first passage of flatus
Incidence of myocardiac injury
Presence of ECG changes (bundle branch block, premature beats, or T-wave changes) or cardiographic enlargement or decreased cardiac function, elevated cTn/T \>14 pg/ml and/or CK/MB elevated \>8.8 ng/ml.
Other outcomes
Mechanical ventilation support time
The duration participants underwent mechanical ventilation.
PACU time
The duration participants admitted in the PACU.
ICU time
The duration participants admitted in the ICU
Hospitalization time
The duration participants in hospitalization.
Sponsors and contacts
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