Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units (NURSIE)
Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Luxembourg、卢森堡
- Centre Hospitalier Emile Mayrisch
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Bruxelles、比利时
- Hopital de Bruxelles
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Charleroi、比利时
- CHU Charleroi
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Charleroi、比利时
- Hôpital Civil Marie Curie
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Besançon、法国
- CHU Besançon
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Boulogne-Billancourt、法国
- CHU Ambroise Pare
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Corbeil-Essonnes、法国
- CH Sud Francilien
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Dax、法国
- CH de Dax
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Draguignan、法国
- CH de la Dracénie
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Lille、法国
- CHRU Lille
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Lille、法国
- Hôpital Jeanne de Flandre
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Marseille、法国
- CHU Marseille
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Nantes、法国
- CHU Nantes
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Nice、法国
- CHU Nice
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Nîmes、法国
- CHU Nimes
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Orléans、法国
- CHR Orléans
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Paris、法国
- Chu Lariboisiere
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Paris、法国
- Chu La Pitie Salpetriere
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Paris、法国
- Hôpital Européen George Pompidou
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Paris、法国
- CHU Necker Enfant Malade
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Strasbourg、法国
- CHU Strasbourg
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Toulouse、法国
- CHU Toulouse
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Valence、法国
- CH VALENCE
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Villeneuve-Saint-Georges、法国
- CHI Lucie & Raymond Aubrac
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A
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Versailles、A、法国
- CH Andre Migniot
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Meyrin、瑞士
- Hôpital de la Tour
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Each participating unit will include all consecutive patients staying in the ICU.
Each day a screening of the patients will be released between 8 and 10 am.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient already included in this study
- Medical contraindication to the bed bath with lateral mobilization
- Withdrawal of life sustaining treatment
- Spinal trauma
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Cohort for nursing care
Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation
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The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)
大体时间：72 hours
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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 :
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72 hours
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合作者和调查者
调查人员
- 研究主任：Mathieu Lloung、French Intensive Care Society
- 学习椅：Jean Baptiste Lascarrou, MD、French Intensive Care Society
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2018-A00046-49
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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