跳至主要内容
临床试验/NCT05522647
NCT05522647招募中不适用

Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Number of risk behaviors observed per one-hour period

研究概览

简要总结

There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.

The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.

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

入选标准

  • Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
  • Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
  • Affiliation to a social security system
  • Hospitalization in the department for at least 9 days
  • Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research

排除标准

  • Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
  • Patient under guardianship, curatorship or safeguard of justice
  • Pregnant and breastfeeding women
  • Refusal to participate

结局指标

主要结局

Number of risk behaviors observed per one-hour period

时间窗: day 9

Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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