Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Grace Lim, MD, MS34 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Anesthesia, Epidural Hypotension

Interventions

ClearSight HPI Monitoring systemDIAGNOSTIC_TEST

Continuous blood pressure monitoring for precision hypotensive event response

Standard of Care Blood Pressure MonitoringDIAGNOSTIC_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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Time-to-treatment of Hypotension (Minutes)

The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups

Time frame: 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."

Time frame: 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."

Time frame: 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."

Data from ClinicalTrials.gov

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Secondary Outcomes

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).