NCT05906368

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Grace Lim, MD, MS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.

Detailed description

In a prospective study, we will achieve the following aims: To determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement. To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.

Conditions

• Anesthesia, Epidural
• Hypotension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ClearSight HPI Monitoring system	Continuous blood pressure monitoring for precision hypotensive event response
DIAGNOSTIC_TEST	Standard of Care Blood Pressure Monitoring	Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.

Timeline

• Start date: 2024-04-18
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2023-06-15
• Last updated: 2025-11-04
• Results posted: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study