Clinical trial NCT05960747: Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
Official title: Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion
Frist Time Indication to Perform a Thoracentesis
Medical Student Training
Keywords: Thoracentesis
Augmented virtual reality simulator
Medical student training
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Primary outcomes:
measure: Assessment of the success rate
timeFrame: 1 day
Secondary outcomes:
measure: Assessment of specific characteristic prior and after thoracocentesis
timeFrame: 1 day
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
state: Bas-Rhin
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: