Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal Anesthesia

Conditions

• Spinal Hypotension

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• ARX Decision-Support Display — OTHER
  A clinician-facing decision-support display that presented real-time 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure during elective cesarean delivery under spinal anesthesia, from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice

Study Details

This single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. The display provides 1-, 2-, and 3-minute MAP forecasts from the time of spinal anesthesia administration until delivery or up to 20 minutes, whichever occurs first. Clinicians continue to manage blood pressure according to usual institutional practice, including phenylephrine infusion and bolus dosing, and retain full autonomy over treatment decisions; the study display does not provide dosing recommendations. The primary objective is to assess the prospective accuracy of short-horizon MAP forecasts. Secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls.

Key Dates

Start date

Jun 16, 2025

Status verified

Apr 2026

Primary completion

Jul 16, 2025

Completion

Jul 16, 2025

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: ARX Decision-Support Display
  Participants undergoing elective cesarean delivery under spinal anesthesia received standard clinical management plus a clinician-facing ARX decision-support display that showed 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice.

Primary Outcome Measure

Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast [ Time Frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. ]

Locations (1)

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