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临床试验/NCT04188093
NCT04188093已完成不适用

Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1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
100
试验地点
1
主要终点
Clinical in-hospital complications

研究概览

简要总结

In the Postoperative Care Unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. This study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (PACU) discharge criteria, a modified Aldretes score. Secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.

详细描述

Patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. Described patient groups are monitored for at least 24 hours in PACU before returning to the ward.

In Denmark physiological parameters are assessed in the PACU every hour until discharge using the DASAIM discharge criteria (A modified Aldrete score).

The PACU discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. Each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem.

The investigators will investigate the predictive value of the PACU discharge criteria and interventions in the PACU setting, to identify patients at risk of developing postoperative complications. Secondary outcome is micro events on the ward. Patients vital signs are monitored continuously from PACU discharge until the 5th postoperative day. Micro events are defined as deviations of vital parameters from normal range.

研究设计

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

入排标准

年龄范围
60 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery
  • Pancreaticoduodenectomy (KJLC30)
  • Transthoracic esophageal resection without interposition (KJCC10)

排除标准

  • Patients not expected to be able to cooperate
  • Patients not cognitive well (Mini Mental State Examination < 24)
  • Pacemaker
  • Patients with allergies including band aid, plastic and silicone

结局指标

主要结局

Clinical in-hospital complications

时间窗: until discharge, up to 90 days

Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions

次要结局

  • bradypnea(During the first 4 postoperative days)
  • Hypotension(During the first 4 postoperative days)
  • Very severe desaturation(During the first 4 postoperative days)
  • Tachypnea(During the first 4 postoperative days)
  • Severe tachypnea(During the first 4 postoperative days)
  • Severe desaturation(During the first 4 postoperative days)
  • Clinical out of hospital complications(until 96 days postoperatively)
  • Bradycardia(During the first 4 postoperative days)
  • Tachycardia(During the first 4 postoperative days)
  • Severe hypotension(During the first 4 postoperative days)

研究者

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

Eske Kvanner Aasvang

Head of research, Clinical professor, Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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