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

Primary Purpose

Lumbar Puncture

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
performing lumbar punctures by students with standard training
training students augmented reality simulator
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Puncture focused on measuring lumbar puncture, simulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group patient

experimental group patient

Arm Description

performing lumbar punctures by students with standard training

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
April 14, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT05269238
Brief Title
Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator
Acronym
APLOSIM
Official Title
Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
June 2, 2023 (Anticipated)
Study Completion Date
June 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Puncture
Keywords
lumbar puncture, simulator

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group patient
Arm Type
Other
Arm Description
performing lumbar punctures by students with standard training
Arm Title
experimental group patient
Arm Type
Experimental
Arm Description
performing lumbar punctures by students with standard training and an augmented reality simulator
Intervention Type
Other
Intervention Name(s)
performing lumbar punctures by students with standard training
Intervention Description
performance of the puncture by the student have been previously trained with standard training
Intervention Type
Other
Intervention Name(s)
training students augmented reality simulator
Intervention Description
performance of the puncture by the student have been previously trained using the augmented reality simulator
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FELTEN Renaud, PH
Phone
03 88 12 88 04
Ext
+33
Email
renaud.felten@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BIGAU KEVIN, PH
Phone
0388128584
Ext
+33
Email
kevin.bigaut@chru-strasbourg.fr
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FELTEN Renaud, PH

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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