Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

NCT05906368 | Completed Results FDA Device

• 1 other identifier: STUDY23030009
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Anesthesia, Epidural; Hypotension

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)

  Epidural placement to 4-hours post-infusion start

• Nausea (Yes/No)

  Epidural placement to 4-hours post-infusion start

• Vomiting (Yes/No)

  Epidural placement to 4-hours post-infusion start

• Total Phenylephrine, mg

  Epidural placement to 4-hours post-infusion start

• Total Ephedrine, mg

  Epidural placement to 4-hours post-infusion start

Study Arms (2)

Conventional Care

SHAM COMPARATOR

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

ClearSight Monitoring

EXPERIMENTAL

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: ClearSight HPI Monitoring system; Diagnostic Test: Standard of Care Blood Pressure Monitoring

Interventions

ClearSight HPI Monitoring system DIAGNOSTIC_TEST

Continuous blood pressure monitoring for precision hypotensive event response

ClearSight Monitoring

Standard of Care Blood Pressure Monitoring DIAGNOSTIC_TEST

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.

ClearSight Monitoring; Conventional Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grace Lim, MD, MS: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Katherine Grace Lim
• Organization: UPMC, University of Pittsburgh

limkg2@upmc.edu

412-641-1778

Study Officials

• Grace Lim, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Chief Obstetric & Women's Anesthesiology

Model Details: Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 15, 2023
• Study Start: April 18, 2024
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)