Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Grace Lim, MD, MS

Status: Completed

Conditions: Hypotension; Anesthesia, Epidural

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05906368

STUDY23030009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Conventional Care

Sham Comparator group

Description:

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.

Treatment:

Diagnostic Test: Standard of Care Blood Pressure Monitoring

ClearSight Monitoring

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ClearSight HPI Monitoring system

Diagnostic Test: Standard of Care Blood Pressure Monitoring