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

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Effusion; Frist Time Indication to Perform a Thoracentesis; Medical Student Training
• Intervention / Treatment: Other: Simulation group

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Benjamin RENAUD-PICARD; Phone Number: +33 3.68.55.01.82; Email: benjamin.renaudpicard@chru-strasbourg.fr
• Study Contact Backup: Name: Maxime FURSTENBERGER; Phone Number: +33 3 69.55.06.45; Email: maxime.furstenberger@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Not yet recruiting
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Romain KESSLER
    • Contact: Sandrine HIRSCHI
    • Contact: Benjamin RENAUD-PICARD; Phone Number: +33368550182; Email: benjamin.renaudpicard@chru-strasbourg.fr
    • Contact: Maxime FURSTENBERGER; Phone Number: +33369550645; Email: maxime.furstenberger@chru-strasbourg.fr
    • Contact: Céline MASCAUX
    • Contact: Benjamin RENAUD-PICARD
    • Contact: Maxime FURSTENBERGER
    • Contact: Cézar MATAU
    • Contact: Adrien COSSART
    • Contact: Fréderic DE BLAY
    • Contact: Tristan DEGOT
    • Contact: Moustapha HUSSEIN
    • Contact: Loic KASSEIGNE
    • Contact: Naji KHAYATH
    • Contact: Justine LEROUX
    • Contact: Christophe MARCOT
    • Contact: Guillaume MARTIN
    • Contact: Bertrand MENNECIER
    • Contact: Carine METZ-FAVRE
    • Contact: Nicolas MIGUERES
    • Contact: Lucile PABST
    • Contact: Guillaume PAMART
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67091
      • Recruiting
      • Hopitaux Universitaire de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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.
• Patients requiring a first-time thoracentesis in routine care

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the success rate	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of specific characteristic prior and after thoracocentesis	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Thoracentesis; Augmented virtual reality simulator; Medical student training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 8809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No