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Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Primary Purpose

Anesthesia, Epidural, Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClearSight HPI Monitoring system
Standard of Care Blood Pressure Monitoring
Sponsored by
Grace Lim, MD, MS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia, Epidural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Magee Womens Hospital of UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Conventional Care

ClearSight Monitoring

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time-to-treatment of hypotension (minutes)
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Ease of use by clinical staff
Clinical nurse reports of ease of use of ClearSight device (likert scale 0 - 5)
Ease of hypotension detection by clinical staff
Clinical nurse reports of ease of hypotension detection using ClearSight device (likert scale 0 - 5)
Satisfaction of ClearSight use by clinical staff
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)
Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Nausea (Yes/No)
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Vomiting (Yes/No)
Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Total phenylephrine, mg
Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Total ephedrine, mg
Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Total intravenous fluids, mL
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)
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
Proportion of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.

Full Information

First Posted
May 8, 2023
Last Updated
October 3, 2023
Sponsor
Grace Lim, MD, MS
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT05906368
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grace Lim, MD, MS
Collaborators
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Epidural, Hypotension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Care
Arm Type
Sham Comparator
Arm 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.
Arm Title
ClearSight Monitoring
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ClearSight HPI Monitoring system
Intervention Description
Continuous blood pressure monitoring for precision hypotensive event response
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of Care Blood Pressure Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time-to-treatment of hypotension (minutes)
Description
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Time Frame
From epidural placement until 4-hours post-infusion start
Title
Ease of use by clinical staff
Description
Clinical nurse reports of ease of use of ClearSight device (likert scale 0 - 5)
Time Frame
report at 4-hour post-infusion
Title
Ease of hypotension detection by clinical staff
Description
Clinical nurse reports of ease of hypotension detection using ClearSight device (likert scale 0 - 5)
Time Frame
report at 4-hour post-infusion
Title
Satisfaction of ClearSight use by clinical staff
Description
Clinical nurse reports of satisfaction of use of ClearSight device (likert scale 0 - 5)
Time Frame
report at 4-hour post-infusion
Secondary Outcome Measure Information:
Title
Total time in hypotension with mean arterial pressure (MAP) <65 mmHg (in minutes)
Description
Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Nausea (Yes/No)
Description
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Vomiting (Yes/No)
Description
Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Total phenylephrine, mg
Description
Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Total ephedrine, mg
Description
Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Total intravenous fluids, mL
Description
Average volume of fluids given to patients in CM and CM+HPI groups
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Total number of reported changes in fetal heart rate category (from healthy to deceleration or excelleration)
Description
Average number of Fetal heart rate decelerations noted within the CM and CM+HPI groups.
Time Frame
Epidural placement to 4-hours post-infusion start
Title
Fetal heart rate decelerations within 1 hour of initiation of ELA
Description
Proportion of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.
Time Frame
Epidural placement to 1-hour post-infusion start

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhnoi Wroble-Biglan, MD, McS
Phone
14126471177
Email
wroblebiglanm@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Barlow
Phone
4126414154
Email
barlowr@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Lim, MD, MSc
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minhnoi Wroble Biglan, PhD
Phone
412-641-1777
Email
wroblebiglanm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Amy Monroe
Phone
4126236382
Email
monroeal@upmc.edu
First Name & Middle Initial & Last Name & Degree
Grace Lim, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

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