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NCT Number: NCT05960747

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopitaux Universitaire de Strasbourg, Strasbourg, Bas-Rhin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simulation group

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Assessment of specific characteristic prior and after thoracocentesis

    Time frame: 1 day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin RENAUD-PICARD

CONTACT

[email protected]

+33 3.68.55.01.82

Maxime FURSTENBERGER

CONTACT

[email protected]

+33 3 69.55.06.45

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ARPEGES

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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