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

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Pleural Effusion; Medical Student Training; Frist Time Indication to Perform a Thoracentesis

Treatments: Other: Simulation group

Study type: Observational

Funder types: Other

Identifiers

NCT05960747

8809

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

340 participants in 2 patient groups

Control group

Description:

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

Description:

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

Treatment:

Other: Simulation group