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临床试验/NCT05046925
NCT05046925Unknown不适用

PACU or ICU for Postoperative Care After Major Thoracic and Abdominal Surgery:a Prospective Randomized Clinical Trial

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 18,000 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18,000
试验地点
1
主要终点
mortality

研究概览

简要总结

The aim of this study is to demonstrate the efficacy and safety of a specialised post-anaesthetic care unit (PACU) to a conventional intensive care unit (ICU) in adult patients after major thoracic and abdominal surgery. A better understanding of PACU for postoperative care is likely to reduce mortality and postoperative complications.

详细描述

With the continuous progress of surgical techniques, the number of major thoracic and abdominal surgeries is also increasing. Although intensive monitoring and initiative treatment benefit patients undergoing major surgery, there is also an increasing demand for intensive care in hospitals, which can lead to capacity limitations in the intensive care unit (ICU). In addition, there is emerging opinion that many patients after major thoracic and abdominal surgery do not require ICU care postoperatively to be provided safe and appropriate care. For hospitals and their staff the challenge is to optimize clinical processes and to optimize the effectiveness of treatment in regard to patient's outcome. Studying patient postoperative care following major thoracic and abdominal surgery exposes many opportunities to the improvement of patient safety, tailor the intensive care resource allocation and consider the costs and benefits of the options.

Postoperative mortality and morbidity remain major challenges, and most of these complications develop during the early postoperative period when patients have left the recovery room. Thus improving the care that patients receive once complications have occurred is crucial for reducing mortality. The post-anesthetic care unit (PACU) provides general to intensive care to immediate postsurgical patients. Patients with major thoracic and abdominal surgery surgeries are often kept in PACU until their condition is stabilized before shifting them to their designated wards or ICU[9]. Ender et al. and Probs et al. showed that treatment in a specialized PACU rather than an ICU, after cardiac surgery leads to earlier extubation, decreased ICU length of stay (LOS) and quicker discharge of hospital without compromising patient safety. Kastrup et al. described, introduction of a PACU staffed with intensivist coverage around the clock might shorten the hospital LOS and more patients can be treated in the same time, due to a better use of resources. Some other study described the transferral to a PACU as an unfavourable option, since equipment, expertise and staffing levels in the PACU are different from the ICU.

The possible solution to this problem might be the inclusion of the PACU in the process of distribution of patients to the different levels of intensive care for ensuring the timely recognition and effective management of postoperative complications in patients after major thoracic and abdominal surgery. The most challenges are to identify those candidates who can be monitored PACU within 24 hours postoperatively, rather than in ICU, and implement change in care paradigms safely.

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

入选标准

  • Aged 18 years and older
  • Undergoing major thoracic and abdominal surgery
  • Postoperative hospital stay expected to be at least one night
  • Patients requiring less than 24 hour stay in PACU or ICU

排除标准

  • Patients aged less than 18 years
  • Not receive major thoracic and abdominal surgery
  • Stay in ICU is over 24 hours
  • Hospital stay is less than 24 hours
  • Patient not signing the informed consensus

结局指标

主要结局

mortality

时间窗: up to 90 days

in-hospital mortality, 30-day and 90-day mortality

次要结局

  • The time of length of stay (LOS)(within 24 hours postoperatively)
  • incidence of care escalation(within 24 hours postoperatively)
  • Incidence of major complications(30 days postoperatively)
  • The time of hospital length of stay (LOS)(up to 30 days)
  • Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery(within 24 hours postoperatively)
  • medical cost(up to 90 days])
  • Ventilation time(up 30 days)
  • Incidence of emergency department (ED) visits(90 days)
  • Anaesthetic resuscitation time(Up to 24 hours)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

xiangming fang

Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

First Affiliated Hospital of Zhejiang University

研究点 (1)

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