ARPEGES: Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960747
Collaborator
(none)
340
1
12
28.3

Study Details

Study Description

Brief Summary

Monocentric study, aiming to assess the improvement of medical students to perform a first-time thoracentesis after training using a specific training using an augmented virtual reality simulator, versus standard training.

Study population: medical students from the department of Respirology (University hospital of Strasbourg), performing their first thoracocentesis in patients having an indication for a first-time thoracocentesis.

This is not an interventional study, no change in patient course being induced because of the study.

After the procedure: use of specific surveys for the patient and for medical students to assess the patient's pain, the patient and the medical student level of anxiety, and the student ability during the procedure.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation group

Study Design

Study Type:
Observational
Anticipated Enrollment :
340 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Control group

Medical students with standard training: theoretical teaching, associated with a real-life demonstration of at least one thoracentesis by a senior doctor from our department

Simulation group

Medical students with standard training + training using an augmented virtual reality simulator specially developed for thoracentesis.

Other: Simulation group
Specific training for medical students by using an augmented virtual reality simulator for thoracentesis

Outcome Measures

Primary Outcome Measures

  1. Assessment of the success rate [1 day]

    Assessment of the success rate to perform a first-time thoracentesis in patients with an indication for this procedure, depending on whether the medical student was trained using an augmented virtual reality simulator, or with standard training

Secondary Outcome Measures

  1. Assessment of specific characteristic prior and after thoracocentesis [1 day]

    Assessment of specific characteristic prior and after thoracocentesis for the patient (pain, anxiety), and for the medical student (theorical knowledge, anxiety, ability during the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Medical students :
Inclusion criteria:
  • Medical students between the 4th and 6th year of their medical course, working in the department of respirology at the University hospital of Strasbourg, France, without any prior experience of thoracocentesis.

  • Older than 18 years old

  • No opposition to participate to the study (signed consent form).

Exclusion criteria:
  • Student with a prior experience of pleural procedure (chest tube, thoracocentesis).
Patients :
Inclusion criteria:
  • Patients requiring a first-time thoracentesis in routine care.

  • Older than 18 years old.

  • Speaking and understanding French.

  • Valid health insurance.

  • No opposition to participate to the study (signed consent form).

Exclusion criteria:
  • Patient with previous experience of pleural procedure (thoracocentesis, chest tube…).

  • Patient having a high-volume pleural effusion according to radiological/ultrasound criteria.

  • Patient with low-volume pleural effusion according to radiological/ultrasound criteria.

  • Patient with poor clinical tolerance of the pleural effusion(respiratory instability, dependence on ventilation machine with positive expiratory pressure…).

  • Patients with higher risk of complication during the procedure (BMI > 35 kg/m², with increased risk of bleeding…).

  • Contraindication to the use of Lidocaine.

  • Local infection.

  • Impossibility to provide detailed information to the patient.

  • Subject under legal protection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT05960747
Other Study ID Numbers:
  • 8809
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Strasbourg, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023