跳至主要内容
临床试验/NCT02950649
NCT02950649终止不适用

Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Perioperative Care in Moderate to High Risk Patients With Poor Functional Status

Loma Linda University3 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2016年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
189
试验地点
3
主要终点
Accuracy of subjective assessment compared to device assessment of cardiac index

研究概览

简要总结

This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.

详细描述

This study seeks to evaluate the impact of using a non-invasive technology to assess flow guided parameters (SV,SVR, dp/dt, CO, etc.) on patient care decisions in the preoperative settings. Patients seen in the preoperative clinic who are undergoing a moderate or high-risk procedure and have less than 4 metabolic equivalents (METs) will be approached to participate in the study .

Once consented, the device will be placed during the preoperative clinic visit and the data will be presented to the care team. Surveys will be completed by the health care provider for each consented patient to determine if the data from the device positively impacted patient care decisions. Specifically, the survey will evaluate if providing information on the patient's cardiovascular function (via the device used for this study) facilitated the health care provider to identify if the patient had reduced cardiovascular function. For the primary outcome, this study will evaluate if this device can assistant the identification of patients with reduced cardiovascular function by providing the flow guided parameter listed above. Secondary markers include the evaluation of perioperative complication rate (composite outcome ) between those that had the non-invasive HD data displayed to the preoperative team vs. not. Additional secondary makers will include: frequency of intraoperative hemodynamic optimization and goal directed fluid therapy administration, health care provider survey results, patient survey on the level of discomfort from wearing the cuff during the study. length of hospital stay, length of intensive care stay, readmission to the hospital within 30 days after hospital discharge, and 30-day postoperative mortality.

Outcome data will be collected using the electronic medical records database available at the investigators institution.

It is the hope of the investigators that this study will demonstrate that by simply applying the preoperative use of the non-invasive hemodynamic technologies one can:

  1. more appropriately identify which patients would benefit from intraoperative hemodynamic monitoring strategies
  2. increase satisfaction of the preoperative assessment by the health care provider
  3. further validate the importance of caring for patients with knowledge of their volume status, contractility, and vascular resistance in other patient care settings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (greater than 18 years of age)
  • ASA classification 3 and 4 level patients with poor functional status,
  • less than 5 metabolic equivalents (METs) -

排除标准

  • < 18 years of age, pregnancy,
  • known severe peripheral artery disease,
  • poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
  • history of Raynaud's,
  • refusal to provide written consent

结局指标

主要结局

Accuracy of subjective assessment compared to device assessment of cardiac index

时间窗: Up to one year from date of randomization

Comparison of cardiac index derived from subjective preoeprative assessment to cardiac index derived from device assessment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa McCabe

Assistant Professor Cardiothoracic Anesthesiology

Loma Linda University

研究点 (3)

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