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

Pleural Effusion Clinical Trial

— ARPEGES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960747
• Other study ID #: 8809
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Strasbourg, France
• Contact: Benjamin RENAUD-PICARD
• Phone: +33 3.68.55.01.82
• Email: benjamin.renaudpicard[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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.	1 day