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OpenTrials
Completed

NCT Number: NCT05269238

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

performing lumbar punctures by students with standard training

Other

performance of the puncture by the student have been previously trained with standard training

training students augmented reality simulator

Other

performance of the puncture by the student have been previously trained using the augmented reality simulator

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: APLOSIM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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