跳至主要内容
临床试验/NCT05335174
NCT05335174招募中不适用

Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study

Sir Mortimer B. Davis - Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Incidence of intraoperative hypotension

研究概览

简要总结

PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

详细描述

Postoperative vascular complications, including myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), stroke, and death occur in up to 18% of surgical patients.1 Hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 Therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. The investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (HPI) parameter of the HemoSphere monitor and Acumen IQ sensor (Edwards Lifesciences, Irvine, CA) to predict postoperative hypotension in surgical patients.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥45 years old
  • Will undergo open colorectal, hepatobiliary, or vascular surgery;
  • Is expected to have an arterial cannula inserted intraoperatively;
  • Has an anticipated stay in PACU for at least 2 hours;
  • Able to provide written informed consent

排除标准

  • Planned admission to ICU;
  • Refusal to participate;
  • Previously enrolled in the study

结局指标

主要结局

Incidence of intraoperative hypotension

时间窗: in 12 months

Describe the incidence of hypotension defined as MAP \<65 intraoperatively.

Incidence of postoperative hypotension

时间窗: in 12 months

Describe the incidence of postoperative hypotension defined as MAP \<65 in the PACU

Hemodynamic changes with treatment of hypotension

时间窗: in 12 months

Described the changes in cardiac index with each medical treatment of a hypotensive episode.

次要结局

  • Sensitivity and Specificity of HPI(in 12 months)
  • Cardiovascular outcomes(in 12 months)

研究者

发起方
Sir Mortimer B. Davis - Jewish General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Yang

Assistant Professor, Department of Anesthesia, Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital

研究点 (1)

Loading locations...

相似试验