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Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

NCT05906368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-11-04

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Grace Lim, MD, MS

    lead OTHER

Principal Investigators

  • Grace Lim, MD, MSc · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2024-08-29
Completion
2024-08-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906368 on ClinicalTrials.gov