Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906368
• Other study ID #: STUDY23030009
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 11, 2026
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Amy Monroe, MPH, MBA
• Phone: 4126236382
• Email: monroeal[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant

• Age = 18 years of age.

• 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

• Incomplete data

Related Conditions & MeSH terms

• Anesthesia, Epidural
• Hypotension

Intervention

Diagnostic Test:
• ClearSight HPI Monitoring system
Continuous blood pressure monitoring for precision hypotensive event response
• 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.

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Grace Lim, MD, MS	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ease of use by clinical staff	Clinical nurse reports of ease of use of ClearSight device (likert scale 0 - 5)	report at 4-hour post-infusion
Primary	Ease of hypotension detection by clinical staff	Clinical nurse reports of ease of hypotension detection using ClearSight device (likert scale 0 - 5)	report at 4-hour post-infusion
Primary	Satisfaction of ClearSight use by clinical staff	Clinical nurse reports of satisfaction of use of ClearSight device (likert scale 0 - 5)	report at 4-hour post-infusion
Secondary	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
Secondary	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
Secondary	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
Secondary	Total phenylephrine, mg	Average phenylephrine dose(s) given to patients in CM and CM+HPI groups	Epidural placement to 4-hours post-infusion start
Secondary	Total ephedrine, mg	Average ephedrine dose(s) given to patients in CM and CM+HPI groups	Epidural placement to 4-hours post-infusion start
Secondary	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
Secondary	Total number of reported changes in fetal heart rate category (from healthy to deceleration or excelleration)	Average number of Fetal heart rate decelerations noted within the CM and CM+HPI groups.	Epidural placement to 4-hours post-infusion start
Secondary	Fetal heart rate decelerations within 1 hour of initiation of ELA	Proportion 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