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临床试验/NCT04195360
NCT04195360Unknown不适用

Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
42
试验地点
1
主要终点
Incidence of orthostatic intolerance

研究概览

简要总结

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

详细描述

In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) > 20 mmHg or a drop >10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.

Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.

This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years and
  • Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
  • Patients that speak and understand Danish
  • Written informed consent

排除标准

  • Pre-existing orthostatic hypotension or intolerance
  • Alcohol or substance abuse
  • everyday treatment with either anxiolytic or antipsychotic medicine
  • Cognitive dysfunction
  • If surgery was converted to general anesthesia or total knee arthroplasty.

结局指标

主要结局

Incidence of orthostatic intolerance

时间窗: 6 hours postoperatively

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

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

次要结局

  • Changes in systolic arterial pressure (SAP) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in diastolic arterial pressure (DAP) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in mean arterial pressure (MAP) 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 heart rate variability (HRV) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in peripheral perfusion index (PPI) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in cerebral perfusion (ScO2) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in muscular perfusion (SmO2) during mobilization(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in haemoglobin (Hgb) concentration(Preoperatively, 6 and 24 hours postoperatively)
  • Changes in C-Reactive Protein(Preoperatively, 6 and 24 hours postoperatively)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Bundsgaard Andersen

Undergraduate Student

Copenhagen University Hospital, Hvidovre

研究点 (1)

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