Pleural EffusionARPEGESNCT05960747
Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
An observational study of Pleural Effusion and Frist Time Indication to Perform a Thoracentesis, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Frist Time Indication to Perform a Thoracentesis, Medical Student Training
- What is being tested?
- Simulation group
- How many people
- 340 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
- 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).
Who cannot join
- Student with a prior experience of pleural procedure (chest tube, thoracocentesis).
- Patients :
- 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…).
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopitaux Universitaire de Strasbourg
Strasbourg, Bas-Rhin, 67091
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Benjamin RENAUD-PICARD, +33368550182, benjamin.renaudpicard@chru-strasbourg.fr
Maxime FURSTENBERGER, +33369550645, maxime.furstenberger@chru-strasbourg.fr
About this study
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.
Read more
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.
- Conditions
- Pleural Effusion, Frist Time Indication to Perform a Thoracentesis, Medical Student Training
- Being tested
- Simulation group
- Keywords
- Thoracentesis, Augmented virtual reality simulator, Medical student training
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation groupOther
Specific training for medical students by using an augmented virtual reality simulator for thoracentesis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Simulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960747
- Sponsor's protocol ID
- 8809
- Acronym
- ARPEGES
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
- ClinicalTrials.gov ID
- NCT05960747
- Acronym / sponsor ID
- ARPEGES / 8809
- Conditions
- Pleural Effusion, Frist Time Indication to Perform a Thoracentesis, Medical Student Training
- Keywords
- Thoracentesis, Augmented virtual reality simulator, Medical student training
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Simulation groupMedical students with standard training + training using an augmented virtual reality simulator specially developed for thoracentesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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).
- Patients requiring a first-time thoracentesis in routine care.
- Older than 18 years old.
Key exclusion criteria (11 listed)
- Student with a prior experience of pleural procedure (chest tube, thoracocentesis).
- 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…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation groupSpecific training for medical students by using an augmented virtual reality simulator for thoracentesis | Other | Simulation group |
Primary outcome
Assessment of the success rate
Time frame: 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
1 secondary outcome
Assessment of specific characteristic prior and after thoracocentesis
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingPhase 4
Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
Pleural Infection Bacterial, Pleural Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Frist Time Indication to Perform a Thoracentesis, run by University Hospital, Strasbourg, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin RENAUD-PICARD (+33 3.68.55.01.82, benjamin.renaudpicard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the success rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.