Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Time-to-treatment of Hypotension (Minutes)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years of age
- •Planning vaginal delivery
- •Receiving epidural labor analgesia (ELA)
排除标准
- •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
结局指标
主要结局
Time-to-treatment of Hypotension (Minutes)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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."
次要结局
- Nausea (Yes/No)(Epidural placement to 4-hours post-infusion start)
- Vomiting (Yes/No)(Epidural placement to 4-hours post-infusion start)
- Total Intravenous Fluids, mL(Epidural placement to 4-hours post-infusion start)
- 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 Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)(Epidural placement to 4-hours post-infusion start)
- Nausea (Yes/No)(Epidural placement to 4-hours post-infusion start)
- Vomiting (Yes/No)(Epidural placement to 4-hours post-infusion start)
- Total Phenylephrine, mg(Epidural placement to 4-hours post-infusion start)
- Total Ephedrine, mg(Epidural placement to 4-hours post-infusion start)
- Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA(Epidural placement to 1-hour post-infusion start)
研究者
Grace Lim, MD, MS
Associate Professor, Chief Obstetric & Women's Anesthesiology
University of Pittsburgh