跳至主要内容
临床试验/NCT03475238
NCT03475238已完成不适用

Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

French Society for Intensive Care26 个研究点 分布在 4 个国家目标入组 262 人开始时间: 2018年3月29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
262
试验地点
26
主要终点
Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)

研究概览

简要总结

Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Health-care affiliated
  • Length of ICU stay < 72 h
  • Patient with endotracheal tube
  • Patient with tracheostomy
  • Patient receiving vasoactives drugs (norepinephrine, epinephrine, Dobutamine)
  • Patient undergoing no invasive ventilation during 1hour minimum of 24 hours before the selection
  • Patient undergoing hight flow oxygen therapy heated and humidified

排除标准

  • Patient already included in this study
  • Medical contraindication to the bed bath with lateral mobilization
  • Withdrawal of life sustaining treatment
  • Spinal trauma

结局指标

主要结局

Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)

时间窗: 72 hours

Determinate incidence of occurrence of at least one SAE (defined below) during the nursing care while the study period (72 hours) The nursing care will be defined as a lateral mobibization and a length of care sup or equal to 10min SAE are considered according to litterature as : * Cardiac arest * Unplanned extubation * Episode of Spo2 riequiring therapeutic intervention * Artificial airway obstruction requiring endotracheal suctionning * Unplanned dislodgements related to lines or catheters drains * Hypotension with therapeutic intervention * Cardiac rhythm disorders with therapeutic intervention * Agitation with therapeutic intervention * Equipment failure or dysfunction * Patient fall * Need for doctor help * Increased intracranial pressure \> 20 mmHg * Acute painful crisis

次要结局

未报告次要终点

研究者

发起方
French Society for Intensive Care
申办方类型
Other
责任方
Sponsor

研究点 (26)

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