Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Epidural, Hypotension

Intervention / Treatment
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* Diagnostic Test: ClearSight HPI Monitoring system
* Diagnostic Test: Standard of Care Blood Pressure Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional Care<br>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<br>* 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.<br>|
| Experimental: ClearSight Monitoring<br>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<br>* Continuous blood pressure monitoring for precision hypotensive event response<br>Diagnostic Test: Standard of Care Blood Pressure Monitoring<br>* 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.<br>|

What is the study measuring?
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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 (likert scale 0 - 5) | report at 4-hour post-infusion | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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) | Average number of Fetal heart rate decelerations noted within the CM and CM+HPI groups. | Epidural placement to 4-hours post-infusion start | 
| 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 |