AI-Assisted Blood Pressure Control During Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
This proof-of-concept randomized controlled trial evaluates a reinforcement learning (RL)-based clinical decision support system for intraoperative hemodynamic management during non-cardiac surgery.
Background: Intraoperative hypotension is common during general anesthesia and is associated with adverse outcomes including acute kidney injury, myocardial injury, and increased mortality. Current hemodynamic management relies on the individual anesthesiologist's clinical judgment, which can vary in consistency and timeliness. An RL-based system that learns optimal vasoactive agent dosing strategies from clinical data may help standardize and improve real-time hemodynamic decision-making.
Purpose: The primary objective is to evaluate whether the RL-based decision support system can learn intraoperative hemodynamic management decisions comparable to those of experienced anesthesiologists, as measured by the mean absolute error (MAE) between RL-recommended and clinician-executed vasoactive agent doses. The secondary objective is to assess whether RL-guided management improves clinical hemodynamic outcomes, including the time-weighted average of hypotension and the percentage of time with mean arterial pressure within the target range.
Participants: Adult patients (aged 18 to 85 years, ASA I-IV) scheduled for elective non-cardiac surgery under general anesthesia with continuous invasive arterial blood pressure monitoring.
Procedures: Participants will be randomly assigned (1:1) to one of two groups. In the RL-guided group, the anesthesiologist will receive real-time vasoactive agent dosing recommendations from the decision support system displayed on a bedside screen; the anesthesiologist retains full clinical autonomy over all final decisions. In the standard care group, the anesthesiologist will manage hemodynamics according to institutional standard practice without input from the system. The patient and the outcomes assessor will be masked to group assignment. Data collection covers the intraoperative period and 30-day postoperative follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 85 years
Scheduled for elective non-cardiac surgery
Receiving intravenous-inhalation combined general anesthesia with tracheal intubation
ASA physical status I to IV
Disqualifiers
Emergency surgery
Continuous infusion of remifentanil or propofol for less than 30 minutes during surgery
Receiving continuous intravenous sedatives other than propofol during the maintenance phase
Receiving continuous intravenous analgesics other than remifentanil during the maintenance phase
Trial design
Design model
Parallel
Treatments tested in this trial
Device: AI Clinical Decision Support System
DeviceAn AI-based software system that provides real-time, on-screen recommendations to the anesthesiologist regarding drug administration and adjustments to maintain optimal patient physiological parameter
Procedure: Standard of Care Anesthesia
Procedure/SurgeryStandard anesthesia management according to institutional guidelines. The attending anesthesiologist makes all clinical decisions based on their expertise and judgment without input from the investigational AI system.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental: RL-Guided Hemodynamic ManagementExperimental treatment 1 intervention
Group B: Active Comparator: Standard Anesthesia CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Absolute Error (MAE) of RL-Recommended Vasoactive Agent Dosing Versus Anesthesiologist-Executed Dosing
The primary outcome is the mean absolute error (MAE) between vasoactive agent doses recommended by the RL-PRAIS system and doses actually administered by the attending anesthesiologist. Vasoactive agents (norepinephrine, phenylephrine, ephedrine) are converted to norepinephrine-equivalent units (NEq, mcg/kg/min). MAE is computed at each 1-minute decision epoch during hemodynamic optimization and averaged across all epochs per patient. Concordance rate is also reported as the proportion of epochs where the RL-recommended dose falls within a clinically acceptable range of the executed dose.
Time frame
From the onset of hemodynamic optimization (15 minutes after surgical incision) until surgical wound closureSecondary outcomes
1
Time-Weighted Average of Mean Arterial Pressure Below 65 mmHg (TWA-MAP < 65 mmHg)
The time-weighted average of hypotension during the hemodynamic optimization period, calculated as the area under the MAP threshold of 65 mmHg (depth in mmHg multiplied by duration in minutes) divided by the total hemodynamic optimization time (minutes). This composite metric integrates both the severity and duration of intraoperative hypotension. Continuous invasive arterial blood pressure data sampled at 5-second intervals are used for calculation via the trapezoidal rule. A lower value indicates better hemodynamic management.
Time frame
From the onset of hemodynamic optimization (15 minutes after surgical incision) until surgical wound closure2
Percentage of Time with MAP in Target Range (MAP TIR 65-100 mmHg)
The proportion of total hemodynamic optimization time during which mean arterial pressure remains within the target range of 65 to 100 mmHg, expressed as a percentage. A higher percentage indicates more stable hemodynamic control.
Time frame
From the onset of hemodynamic optimization (15 minutes after surgical incision) until surgical wound closure3
Incidence of Intraoperative Hypotensive Events
The number of discrete hypotensive events per patient, defined as episodes where MAP falls below 65 mmHg for at least 1 minute continuously. An event is considered terminated when MAP returns to 65 mmHg or above for at least 1 minute.
Time frame
From the onset of hemodynamic optimization (15 minutes after surgical incision) until surgical wound closure4
TWA-MAP Below 60 mmHg and Below 55 mmHg
Time-weighted average of MAP below 60 mmHg and below 55 mmHg, calculated using the same method as TWA-MAP \< 65 mmHg but with lower thresholds. These metrics capture moderate and severe intraoperative hypotension, respectively.
Time frame
From the onset of hemodynamic optimization (15 minutes after surgical incision) until surgical wound closureOther outcomes
1
Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days
Composite endpoint including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and new-onset heart failure within 30 days of surgery, assessed through medical record review and follow-up telephone contact.
Time frame
30 days after surgery2
Acute Kidney Injury (AKI) Within 7 Days
Incidence of acute kidney injury within 7 postoperative days, defined by KDIGO Stage 1 or higher: increase in serum creatinine by 0.3 mg/dL within 48 hours, or increase to 1.5 times baseline within 7 days, or urine output less than 0.5 mL/kg/h for 6 hours.
Time frame
7 days after surgery3
Perioperative Myocardial Injury (PMI)
Elevation of high-sensitivity cardiac troponin above the 99th percentile upper reference limit within the first 3 postoperative days.
Time frame
3 days after surgery4
Duration of Post-Anesthesia Care Unit (PACU) Stay
Time from PACU admission to PACU discharge, measured in minutes.
Time frame
Day of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Peking University People's Hospital
Collaborator
Source ClinicalTrials.gov
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