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

Lumbar Puncture Clinical Trial

— APLOSIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269238
• Other study ID #: 8074
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: FELTEN Renaud, PH
• Phone: 03 88 12 88 04
• Email: renaud.felten[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Puncture
• Wounds and Injuries

Intervention

Other:
• performing lumbar punctures by students with standard training
performance of the puncture by the student have been previously trained with standard training
• training students augmented reality simulator
performance of the puncture by the student have been previously trained using the augmented reality simulator

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 days