NCT05960747

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

July 17, 2023

Last Update Submit

March 31, 2025

Conditions

Pleural EffusionFrist Time Indication to Perform a ThoracentesisMedical Student Training

Keywords

ThoracentesisAugmented virtual reality simulatorMedical student training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of specific characteristic prior and after thoracocentesis

    1 day

Study Arms (2)

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

Simulation group

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

Other: Simulation group

Interventions

Simulation groupOTHER

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

Simulation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • \- Student with a prior experience of pleural procedure (chest tube, thoracocentesis).
  • Patients :
  • 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).
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Central Study Contacts

Benjamin RENAUD-PICARD

CONTACT

+33 3.68.55.01.82benjamin.renaudpicard@chru-strasbourg.fr

Maxime FURSTENBERGER

CONTACT

+33 3 69.55.06.45maxime.furstenberger@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 27, 2023

Study Start

February 15, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations

FR(2)