ClinicalTrials.gg
RecruitingNCT05960747ARPEGESUpdated Apr 3, 2025

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

An observational study in Pleural Effusion, Frist Time Indication to Perform a Thoracentesis and Medical Student Training, sponsored by University Hospital, Strasbourg, France. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
340
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

Keywords

  • Thoracentesis
  • Augmented virtual reality simulator
  • Medical student training
03

In context

Pleural Effusion

241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.

This study's planned enrollment of 340 is above the median of 140 across 93 observational studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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 ( > 35 kg/m², with increased risk of bleeding...).
  • to the use of Lidocaine.
  • Local infection.
  • Impossibility to provide detailed information to the patient.
  • Subject under legal protection.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSimulation group

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

06

What researchers measure

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

    Time frame: 1 day

Secondary outcomes

  1. Assessment of specific characteristic prior and after thoracocentesis

    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.

    Time frame: 1 day

07

Study locations

1 of 2 sites recruiting
  • Hopitaux Universitaire de Strasbourg
    Strasbourg, Bas-Rhin 67091, France
    Recruiting
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
    Not yet recruiting
    • Benjamin RENAUD-PICARD · Contactbenjamin.renaudpicard@chru-strasbourg.fr · +33368550182
    • Maxime FURSTENBERGER · Contactmaxime.furstenberger@chru-strasbourg.fr · +33369550645
    • Benjamin RENAUD-PICARD · Principal investigator
    • Maxime FURSTENBERGER · Sub investigator
    • Cézar MATAU · Sub investigator
    • Adrien COSSART · Sub investigator
    • Fréderic DE BLAY · Sub investigator
    • Tristan DEGOT · Sub investigator
    • Sandrine HIRSCHI · Sub investigator
    • Moustapha HUSSEIN · Sub investigator
    • Loic KASSEIGNE · Sub investigator
    • Romain KESSLER · Sub investigator
    • Naji KHAYATH · Sub investigator
    • Justine LEROUX · Sub investigator
    • Christophe MARCOT · Sub investigator
    • Guillaume MARTIN · Sub investigator
    • Céline MASCAUX · Sub investigator
    • Bertrand MENNECIER · Sub investigator
    • Carine METZ-FAVRE · Sub investigator
    • Nicolas MIGUERES · Sub investigator
    • Lucile PABST · Sub investigator
    • Guillaume PAMART · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Feb 2026, 24 months after the start.

Of 35 observational studies under Pleural Effusion, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2023
First posted
Jul 27, 2023
StartActual
Feb 15, 2024
Primary completionEst.
Feb 2026
CompletionEst.
Feb 2026
Last update
Apr 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05960747
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Feb 15, 2024
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Apr 3, 2025

Study contacts

Benjamin RENAUD-PICARD
Contact
benjamin.renaudpicard@chru-strasbourg.fr
+33 3.68.55.01.82
Maxime FURSTENBERGER
Contact
maxime.furstenberger@chru-strasbourg.fr
+33 3 69.55.06.45

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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