Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

NCT ID: NCT05906368

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2024-08-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Standard of Care Blood Pressure Monitoring

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

ClearSight HPI Monitoring system

Intervention Type: DIAGNOSTIC_TEST

Continuous blood pressure monitoring for precision hypotensive event response

Standard of Care Blood Pressure Monitoring

Intervention Type: 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.

Interventions

ClearSight HPI Monitoring system

Continuous blood pressure monitoring for precision hypotensive event response

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Grace Lim, MD, MS

OTHER

Sponsor Role: lead

Responsible Party

Grace Lim, MD, MS

Associate Professor, Chief Obstetric & Women's Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Grace Lim, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY23030009

Identifier Type: -

Identifier Source: org_study_id