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

NCT ID: NCT05960747

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion Frist Time Indication to Perform a Thoracentesis Medical Student Training

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Simulation group

Medical students with standard training + training using an augmented virtual reality simulator specially developed for thoracentesis.

Simulation group

Intervention Type OTHER

Specific training for medical students by using an augmented virtual reality simulator for thoracentesis

Interventions

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Simulation group

Specific training for medical students by using an augmented virtual reality simulator for thoracentesis

Intervention Type OTHER

Eligibility Criteria

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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).


* 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

\- 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…).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, France

Site Status RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Benjamin RENAUD-PICARD

Role: CONTACT

+33 3.68.55.01.82

Maxime FURSTENBERGER

Role: CONTACT

+33 3 69.55.06.45

Facility Contacts

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Benjamin RENAUD-PICARD

Role: primary

+33368550182

Maxime FURSTENBERGER

Role: backup

+33369550645

Other Identifiers

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8809

Identifier Type: -

Identifier Source: org_study_id

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