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临床试验/NCT03743116
NCT03743116已完成不适用

Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Incidence of orthostatic hypotension

研究概览

简要总结

Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

详细描述

Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization.

Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.

The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Patients that speak and understand Danish
  • Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

排除标准

  • Alcohol or drug abuse
  • Cognitive dysfunction
  • Known orthostatic hypotension
  • Use of anxiolytic drugs

结局指标

主要结局

Incidence of orthostatic hypotension

时间窗: 6 hours postoperatively

Orthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

Incidence of orthostatic intolerance

时间窗: 6 hours postoperatively

Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization

次要结局

  • Changes in mean arterial pressure (MAP) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in diastolic arterial pressure (DAP) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in cardiac output (CO) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in systemic vascular resistance (SVR) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in stroke volume (SV) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in systolic arterial pressure (SAP) during mobilization(Preoperatively, 6 and 24 hours postoperatively)

研究者

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

Ana-Marija Hristovska

Principal Investigator, Medical Doctor

Hvidovre University Hospital

研究点 (1)

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