Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Study Details
Study Description
Brief Summary
The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in the labor and delivery unit at Magee-Women's hospital 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Despite decades of safe use, hypotension after epidural labor analgesia (ELA) remains the most common complication, experienced by an average of 1 of every 5 patients receiving ELA. Hypotension has safety ramifications to both mother and fetus and results in, at its mildest, maternal lightheadedness and nausea, and at its most severe, fetal acidemia and difficulties with fetal-to-neonatal transition. These safety concerns make early detection, prevention, and treatment of ELA-associated hypotension a critical component of safety on labor & delivery units worldwide.
Currently, conventional monitoring involves intermittent non-invasive blood pressure checks to detect and treat hypotension. The current American Society of Anesthesiologists Guidelines on Obstetric Anesthesia Practice recommend monitoring for hypotension, with most practices using non-invasive cuff measures, typically expected every 5-15 minutes. However, intermittent monitoring potentially results in delays in recognition and treatment of low blood pressure. Delays in treating epidural anesthesia-associated hypotension can result in inadequate maternal-fetal perfusion. Further, causes of hypotension after neuraxial in obstetric patients are primarily driven by reductions in systemic vascular resistance (SVR). Early detection of ELA-associated hypotension is critically needed to facilitate earlier treatments with vasopressors, typically consisting of either ephedrine or phenylephrine. Our proposed solution involves using the hypotension prediction index (HPI, ClearSight, Edwards Lifesciences, Irvine, USA) to reduce time-to-treatment of epidural labor analgesia (ELA)-associated hypotension. The purpose of this study is to assess the utility of HPI in ELA compared to conventional monitoring, for the benefits of reduced time-to-treatment of ELA-associated hypotension.
Specific Aim 1: 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.
Specific Aim 2: 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.
-
Research Key Questions(s): Can hypotension prediction index (HPI, ClearSight, Edwards Lifesciences, Irvine, USA) reduce time-to-treatment of epidural labor analgesia (ELA)-associated hypotension?
-
Hypotheses: Use of HPI will have clinically significant reductions in time-to-treatment of ELA-associated hypotension compared to conventional non-invasive blood pressure monitoring methods.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Conventional Care 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
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.
|
| Experimental: ClearSight Monitoring 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
Continuous blood pressure monitoring for precision hypotensive event response
Diagnostic Test: Standard of Care Blood Pressure Monitoring
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.
|
Outcome Measures
Primary Outcome Measures
- 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 (likert scale 0 - 5)
- Ease of hypotension detection by clinical staff [report at 4-hour post-infusion]
Clinical nurse reports of ease of hypotension detection using ClearSight device (likert scale 0 - 5)
- Satisfaction of ClearSight use by clinical staff [report at 4-hour post-infusion]
Clinical nurse reports of satisfaction of use of ClearSight device (likert scale 0 - 5)
Secondary Outcome Measures
- 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
- 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]
Average number of Fetal heart rate decelerations noted within the CM and CM+HPI groups.
- Fetal heart rate decelerations within 1 hour of initiation of ELA [Epidural placement to 1-hour post-infusion start]
Proportion of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Grace Lim, MD, MS
- Edwards Lifesciences
Investigators
- Principal Investigator: Grace Lim, MD, McS, University of Pittsburgh Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY23030009