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Recruiting NCT05960747

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simulation group.
Who it may be relevant to
Registry conditions: Pleural Effusion, Frist Time Indication to Perform a Thoracentesis, Medical Student Training. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Assessment of the success rate [Time frame: 1 day]
Secondary outcome measures (1)
  • Assessment of specific characteristic prior and after thoracocentesis [Time frame: 1 day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 2 centers
  • Hopitaux Universitaire de Strasbourg — Strasbourg
  • Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT05960747 · 8809

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗