NCT05960747 Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
| NCT ID | NCT05960747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Pleural Effusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 340 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 340 participants in total. It began in 2024-02-15 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05960747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Effusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05960747 currently recruiting?
Yes, NCT05960747 is actively recruiting participants. Contact the research team at benjamin.renaudpicard@chru-strasbourg.fr for enrollment information.
Where is the NCT05960747 trial being conducted?
This trial is being conducted at Strasbourg, France, Strasbourg, France.
Who is sponsoring the NCT05960747 clinical trial?
NCT05960747 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 340 participants.