Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07123675 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

AI-Assisted Blood Pressure Control During Anesthesia

Study acronym: RL-PRAIS PoC
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Nov 30, 2025 to Jun 1, 2027v2 Show 6 more changesShow less
    • Start date: Sep 1, 2025 to Jun 1, 2026
    • Primary endpoint revised
    • Study completion date: Dec 15, 2025 to Dec 15, 2027
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 4 to 7
    • Study description expanded, about 259 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07123675
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Collaborators: Peking University People's Hospital
Conditions
(from sponsor)
Intraoperative Hypotension, Hemodynamic Instability
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov