Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
- Conditions
- HypotensionAnesthesia, Epidural
- Registration Number
- NCT05906368
- Lead Sponsor
- Grace Lim, MD, MS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
- Pregnant
- Age ≥ 18 years of age
- Planning vaginal delivery
- Receiving epidural labor analgesia (ELA)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time-to-treatment of Hypotension (Minutes) From epidural placement until 4-hours post-infusion start The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Ease of Use by Clinical Staff report at 4-hour post-infusion 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."
Ease of Hypotension Detection by Clinical Staff report at 4-hour post-infusion 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."
Satisfaction of ClearSight Use by Clinical Staff report at 4-hour post-infusion 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."
- Secondary Outcome Measures
Name Time Method Total Intravenous Fluids, mL Epidural placement to 4-hours post-infusion start Average volume of fluids given to patients in CM and CM+HPI groups
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration) Epidural placement to 4-hours post-infusion start Total number of participants who experienced changes in fetal heart rate category (any)
Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes) Epidural placement to 4-hours post-infusion start Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Nausea (Yes/No) Epidural placement to 4-hours post-infusion start Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Vomiting (Yes/No) Epidural placement to 4-hours post-infusion start Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Total Phenylephrine, mg Epidural placement to 4-hours post-infusion start Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Total Ephedrine, mg Epidural placement to 4-hours post-infusion start Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA Epidural placement to 1-hour post-infusion start Percentage of patients who experience any fetal heart rate deceleration event \[Presence (Yes) or absence (No)\] within 1-hour of epidural placement.
Trial Locations
- Locations (1)
Magee Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Magee Womens Hospital of UPMC🇺🇸Pittsburgh, Pennsylvania, United States