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临床试验/NCT05269238
NCT05269238已完成不适用

Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.

研究概览

简要总结

Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.

The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Requiring a lumbar puncture as part of their routine care
  • Male or female of legal age with no upper age limit
  • French speaking
  • Subject affiliated to a social health insurance scheme
  • Not having expressed his or her opposition to the re-use of his or her data in the context of this research

排除标准

  • Previously undergone a lumbar puncture
  • BMI > 35 kg/m².
  • Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
  • Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
  • Subject under court protection
  • Subject under guardianship or curatorship
  • Contraindication to the use of Emlapatch

研究组 & 干预措施

control group patient

Other

performing lumbar punctures by students with standard training

干预措施: performing lumbar punctures by students with standard training (Other)

experimental group patient

Experimental

performing lumbar punctures by students with standard training and an augmented reality simulator

干预措施: training students augmented reality simulator (Other)

结局指标

主要结局

Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.

时间窗: 3 days

Success rate of lumbar puncture as assessed by the collection of cerebrospinal fluid (CSF) at the end of the procedure. A successful LP is defined as the collection of CSF at the end of the procedure performed by the student without the assistance of a senior physician or resident and without interruption of the procedure by the patient.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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