Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Sup… (NCT05960747) | Clinical Trial Compass
RecruitingNot Applicable
Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
France340 participantsStarted 2024-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.