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临床试验/NCT04007432
NCT04007432招募中不适用

Nocturnal Hypoxia in Patients Hospitalized in Orthogeriatrics After Hip Fracture

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
4
主要终点
Delirium

研究概览

简要总结

Delirium is a common complication following hip fracture surgery (HFS) in older people. Postoperative hypoxia has also been associated with delirium, but not specifically in geriatric patients. The aim of the study is to demonstrate that post-operative hypoxia is associated with in-hospital complications in patients with HFS.

详细描述

Patients hospitalized in orthogeriatric unit after HFS will be monitored for nocturnal SpO2 with a pulse oximeter continuously during 3 nights. In-hospital complications will be recorded prospectively in all patients, especially the occurrence of delirium with the CAM scale. The hypoxia vs non-hypoxia (more than 20% of the time spent with SpO2<90%) groups will be analyzed for clinical characteristics, comorbidities and medication use.

The statistical association between severe post-operative nocturnal hypoxemia and occurrence of delirium will be assessed. The dependance between this association and daytime SpO2 will also be assessed. The potential confirmation of an association between post-operative nocturnal hypoxemia in patients with HFS and the occurrence of delirium will lead the reflection on a clinical trial testing the benefit of oxygen therapy in the prevention of post-operative delirium, to improve the medical care of orthogeriatric patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 70 years old,
  • hospitalized in orthogeriatrics for hip fracture surgery
  • information about the study and expression of non opposition
  • Expected hospital stay of 5 nights or more

排除标准

  • patient under guardianship,
  • any other type of fracture associated,
  • oxymetry recording not possible (behavioral disorders, night stirring,...)

研究组 & 干预措施

Older patients with hip fracture

Experimental

Older patients admitted for hip fracture surgery

干预措施: pulse oxymeter (Other)

结局指标

主要结局

Delirium

时间窗: Month 1

Delirum or not, diagnosed with CAM (Confusion Assessment Method). Association between nocturnal hypoxia and delirium will be study.

次要结局

  • In-hospital complications(Month 1)
  • Length of hospitalisation stay in othogeriatrics unit(Month 1)
  • walking speed (functional status)(Month 1)
  • walking status (functional status)(Month 1)
  • Physical performance (functional status)(Month 1)
  • Dependency(Month 6)
  • Mortality(Month 6)
  • Nocturnal hypercapnia(Month 1)
  • Dependency(Month 1)
  • Mortality(Month 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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