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临床试验/NCT04333719
NCT04333719已完成不适用

Prevalence of Deep Sedation in Terminal Palliative Phase

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2020年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
183
试验地点
1
主要终点
Determine the number of patient with deep sedation

研究概览

简要总结

This nation-wide, multicentric, prospective and cross-sectional study aims to estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility (palliative care units, dedicated beds in acute units, mobile teams for inpatient or outpatients or home-based structures) in France.

详细描述

Inducing a deep sedation in palliative care is a sensitive practice. The abolition of the communication in a crucial moment of life for the patients is particularly challenging. This practice implies particular experiences for families and caregivers, often increased by the deepness of the sedation. In France, the Claeys-Leonetti law has added additional indications of deep sedation. The lack of data on the prevalence of this practice in palliative care complicates the implementation of research projects and the improvement of professionals skills. In existing literature, the proportions of patients thus sedated varied from 2.5 to 14.5%. To our knowledge, no study on the prevalence of deep sedative practices in terminal diseases has been carried out in France. This observational study will help to better understand the real importance of this practice among each palliative care structures. They will also serve to build research projects on this theme supporting improvement of care for this population.

In this study, the deep sedation is defined as a sedation directly inducing from the induction time a score of -4 or -5 at the Richmond vigilance scale (or a clinically equivalent state for the investigator) as defined by the French society of palliative care and accompanying.

The day of inclusion, the investigator will collect the information about the structure of palliative care (type, team composition, number of patients with an on-going terminal disease), the characteristics of the sedated patient(s) (age, disease, treatments) and of the sedation (sedative molecules, assessment of vigilance, consents and decision-making process). In case of an on-going sedation previously initiated but still in progress the day of inclusion, the investigator will retrospectively collect the required data.

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

入选标准

  • Major, minor, major with legal protection patient
  • Follow-up by a specialized palliative care facility;
  • Palliative situation of a disease (non-curable);
  • In terminal palliative phase (life expectancy estimated by the investigator =< 4 weeks)

排除标准

  • Not followed by a specialized palliative care facility;
  • In curative situation (curable);
  • In non-terminal palliative phase (life expectancy estimated by the investigator > 4 weeks).

结局指标

主要结局

Determine the number of patient with deep sedation

时间窗: Month 60

The primary endpoint will be the prevalence of deep sedations among all the included patients with a terminal disease receiving cares from a specialized palliative care facility.

次要结局

  • Determine the number of patient by type of disease(Day 60)
  • Describe the sedative therapies used(Day 60)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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