Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Anesthesia, Epidural
• Intervention / Treatment: Diagnostic test: Standard of Care Blood Pressure Monitoring; Diagnostic test: ClearSight HPI Monitoring system

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant
• Age ≥ 18 years of age
• Planning vaginal delivery
• Receiving epidural labor analgesia (ELA)

Exclusion Criteria:

• Non-reassuring fetal tracing at the time of ELA request
• Contraindications to ELA
• Significant cardiac arrhythmias or aortic regurgitation
• Arrhythmia
• Treatment with antihypertensive medications
• Pre-eclampsia with or without severe features
• Preoperative infection
• Inability to use ClearSight device for any reason
• Non-English fluency
• Sustains unintentional dural puncture
• Incomplete data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Conventional Care; Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.	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.
Experimental: ClearSight Monitoring; Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.	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.; Diagnostic test: ClearSight HPI Monitoring system; Continuous blood pressure monitoring for precision hypotensive event response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-treatment of Hypotension (Minutes)	The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups	From epidural placement until 4-hours post-infusion start
Ease of Use by Clinical Staff	Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."	report at 4-hour post-infusion
Ease of Hypotension Detection by Clinical Staff	Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."	report at 4-hour post-infusion
Satisfaction of ClearSight Use by Clinical Staff	Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."	report at 4-hour post-infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea (Yes/No)	Proportion of patients by group reporting nausea within 4-hours of post-epidural placement	Epidural placement to 4-hours post-infusion start
Vomiting (Yes/No)	Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement	Epidural placement to 4-hours post-infusion start
Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)	Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).	Epidural placement to 4-hours post-infusion start
Total Phenylephrine, mg	Average phenylephrine dose(s) given to patients in CM and CM+HPI groups	Epidural placement to 4-hours post-infusion start
Total Ephedrine, mg	Average ephedrine dose(s) given to patients in CM and CM+HPI groups	Epidural placement to 4-hours post-infusion start
Total Intravenous Fluids, mL	Average volume of fluids given to patients in CM and CM+HPI groups	Epidural placement to 4-hours post-infusion start
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)	Total number of participants who experienced changes in fetal heart rate category (any)	Epidural placement to 4-hours post-infusion start
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA	Percentage of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.	Epidural placement to 1-hour post-infusion start

Collaborators and Investigators

• Sponsor: Grace Lim, MD, MS
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Grace Lim, MD, MSc, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): August 29, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: STUDY23030009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No