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临床试验/NCT03491137
NCT03491137已完成不适用

Wireless Assessment of Respiratory and Circulatory Distress in Surgical Patients

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2018年2月22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
505
试验地点
2
主要终点
Any serious adverse event

研究概览

简要总结

A high percentage of patients undergoing major abdominal surgery will develop a postoperative complication. Our hypothesis is that by observing postoperative patients with continuous wireless monitoring, it is possible to detect the correlation between deviating vital parameters and subsequent postoperative complications. A prospective observational study will take place on general surgical wards with the enrolment of 500 patients in two different hospitals. Physiological parameters will be recorded for 96 hours postoperative. Data is collected preoperative, peroperative and postoperative in up to 6 months for data analyzing.

详细描述

An estimated > 230 million cases of major surgery are performed worldwide annually. Surgical interventions come with an inherent risk of complications. 15 - 30 % of all patients undergoing major abdominal surgery will develop a severe complication post-operative. These numbers correspond to the reported high postoperative in-hospital mortality, 8-9% after major upper abdominal surgery, increased in case of co-morbidities. Part of the high morbidity and mortality may be a result of delayed detection of severe complications due to the lower monitoring frequency in the general wards compared to the Post Anaesthesia Care Unit (PACU) and Intensive Care Unit (ICU). Improved observation may result in earlier detection and subsequently the possibility to implement interventions to divert a negative trajectory and ultimately reduce morbidity and mortality.

This study wish to investigate the correlation between deviating physiological parameters and postoperative complications.

In a prospective observational study, 500 patients enrolled for major abdominal cancer surgery at Rigshospitalet or Bispebjerg Hospital will be included after a signed declaration of consent.

Demographic data will be recorded together with preoperative spirometry, timed-up-and-go, Mini Mental State Examination and an electrocardiogram.

Post-operative when leaving the PACU, a wireless continuous monitoring system will be attached to the patients. The monitoring system will be recording the vital parameters 24/7.

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

入选标准

  • Patient > 60 years old
  • Elective operation performed at Bispebjerg Hospital or Rigshospitalet.
  • Elective major abdominal cancer surgery.
  • Operation estimated to last more than 2 hours.

排除标准

  • Mortality.
  • Non-cooperative patients.
  • Patients with mini mental state examination score <
  • Patients allergic to plaster or silicone.
  • Patients with ICD or pacemaker

结局指标

主要结局

Any serious adverse event

时间窗: within 30 days after inclusion

e.g cardiac arrest, ICU admission, acute myocardial infarction, sepsis, stroke, acute kidney injury, pneumonia or other serious adverse events (defined in Protocol Appendix A)

次要结局

  • Mortality(6 months postoperative)
  • Readmission(6 months postoperative)

研究者

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

Camilla Haahr-Raunkjær

MD, principal investigator

Bispebjerg Hospital

研究点 (2)

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