Hypotension Prediction Index and Intraoperative Hypotension Incidence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • HPI guided hemodynamic management

    Procedure/Surgery

    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

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: standard arterial line groupSham comparator 1 intervention
Group B: HPI guided hemodynamic management groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From anesthesia to end of operation, assessed up to 8 hours.

Secondary outcomes

1

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.

Time frame
From end of operation to 48 hours after operation, up to 48 hours.
2

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.

Time frame
From end of operation to first bowel movement, assessed up to 48 hours.
3

Intestinal function recovery time

Time from end of operation to first passage of flatus

Time frame
From end of operation to first passage of flatus, assessed up to 48 hours.
4

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.

Time frame
From end of operation to 7 days after operation, up to 7 days.

Other outcomes

1

Mechanical ventilation support time

The duration participants underwent mechanical ventilation.

Time frame
From anesthesia induction to anesthesia recovery, assessed up to 24 hours.
2

PACU time

The duration participants admitted in the PACU.

Time frame
From admitted in PACU to discharged from PACU, assessed up to 24 hours.
3

ICU time

The duration participants admitted in the ICU

Time frame
From admitted in ICU to discharged from ICU, assessed up to 3 days.
4

Hospitalization time

The duration participants in hospitalization.

Time frame
From admission to discharge, assessed up to 15 days.

Sponsors and contacts

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