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Recruiting Observational

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

NCT05960747 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-02-15
Last updated
2025-04-03

Condition(s) studied

Pleural EffusionFrist Time Indication to Perform a ThoracentesisMedical Student Training

Investigational drug(s) / intervention(s)

Simulation group

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
Hopitaux Universitaire de Strasbourg Strasbourg Bas-Rhin Recruiting
Hôpitaux Universitaires de Strasbourg Strasbourg France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05960747 on ClinicalTrials.gov ↗ ← All trials in France