跳至主要内容
临床试验/NCT04452487
NCT04452487Unknown不适用

Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments

University Hospital, Clermont-Ferrand3 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2020年6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
2,500
试验地点
3
主要终点
decisions of limitations and therapeutic stops

研究概览

简要总结

This survey is performed to examine if during the Covid's crisis, the practitionner's have respected the modalities of the law about the end of life, in particular concerning limitations and stop of therapeutics

详细描述

In the current legislativ context notably the Clayes Leonetti law, a very large majority of ICU (Intensive Care Unit) patients die with the establishement of a procedure for the limitation and cessation of therapeutics (LAT). During a viral pandemic, medical resources can be saturated, limiting reflexive abilities in favour of binary decisions. This sorting of patients leads to LAT that could be performed without the elementary modalities stated by the law. Thus, arbitrary medical decisions made alone could expose patients to unjustified " loss of luck ". Increasing the resources mobilized during a pandemic must not make us forget the quality of care provided for the benefit of quantity. In therefore seems legitimate to keep the LAT modalities to ensure our ethical principles. No work in the literature based on actual facts explores the impact of a pandemic on compliance with and maintenance of ethical principles and the legisltaive framework, in particular as regards the procedures of the application of LAT.

The purpose of this study is to assess whether the terms of the LAT are being complied during a pandemic for patients with or without Covid.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Hospitalized major patient
  • Infected or not with Covid-19
  • having a management with a LAT defined by an anticipated or factual restriction of a therapeutic resource ( organ replacement, specific treatment) while his or her state of health requires or may require it, leading or not a death. The patient's death occurs either after a cariac massagewhich corresponds to a maximum management with therapeutic failure or within the framework or in the context of brain death, in these cases there is no LAT ; either without cardiac massage and in this case there is de facto a LAT wether or not it is performed according to legisltaive procedures. All patients who die will beclassified according to this diagram for the inclusion criterion. For surviving patients, an analysis of the record in search of LAT elments will be performed. In the absence of LAT elment in the record, i twill be considered that the patient did not have LAT and therfore will not be included.

排除标准

  • 未提供

结局指标

主要结局

decisions of limitations and therapeutic stops

时间窗: at the end of patient's hospitalization, an average of one month

The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record

次要结局

  • Characteristics of the notification of LAT procedure(at the end of patient's hospitalization, an average of one month)
  • Characteristics of consultant's reasoned opinion for the LAT procedure(at the end of patient's hospitalization, an average of one month)
  • gendrer of physicians(Day 0)
  • Characteristics of physicians(Day 0)
  • patient's history(day 0)
  • Characteristics of affected organ(day 0)
  • Characteristics of patients(day 0)
  • COVID-19 patient's status(day 0)
  • Exparience of physicians(Day 0)
  • Characteristics of the LAT procedure (persons who participated to the collegial discussion)(at the end of patient's hospitalization, an average of one month)
  • Characteristics of units(day 0)
  • Age of physicians(Day 0)
  • Age of patients(day 0)
  • final patient status(day 0)
  • Characteristics of the LAT procedure(at the end of patient's hospitalization, an average of one month)
  • Characteristics of hospitalization's patients(day 0)
  • patient's environnement(day 0)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验