Clinical trial NCT05906368: Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Official title: Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Epidural
Hypotension
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2023-06-15
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time-to-treatment of hypotension (minutes)
timeFrame: From epidural placement until 4-hours post-infusion start
measure: Ease of use by clinical staff
timeFrame: report at 4-hour post-infusion
measure: Ease of hypotension detection by clinical staff
timeFrame: report at 4-hour post-infusion
measure: Satisfaction of ClearSight use by clinical staff
timeFrame: report at 4-hour post-infusion
Secondary outcomes:
measure: Total time in hypotension with mean arterial pressure (MAP) <65 mmHg (in minutes)
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Nausea (Yes/No)
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Vomiting (Yes/No)
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Total phenylephrine, mg
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Total ephedrine, mg
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Total intravenous fluids, mL
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Total number of reported changes in fetal heart rate category (from healthy to deceleration or excelleration)
timeFrame: Epidural placement to 4-hours post-infusion start
measure: Fetal heart rate decelerations within 1 hour of initiation of ELA
timeFrame: Epidural placement to 1-hour post-infusion start
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: