Virtual Reality in Awake Surgery : Pilot Study VIRAS

Last updated: November 20, 2024
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

Monitoring of the device

Acceptability of the device

Training session with the virtual reality mask

Clinical Study ID

NCT05151822
29BRC21.0039 (VIRAS)
  • Ages 18-75
  • All Genders

Study Summary

The virtual reality mask is a tool likely to improve the conditions for performing awake surgery:

  • by improving tolerance for the patient,

  • by improving ergonomics in the operating room.

In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria :

  • Major subject

  • Consent for the study

  • Patients eligible for orthopedic surgery with local anesthetic block

  • Estimated duration of the Orthopedic surgery of minimum 1 hour

Exclusion Criteria :

  • Age < 18 years, Age > 75 years,

  • Known central neurological pathology/cognitive impairment,

  • Mini-Mental State examination (MMSe) < 23 if no school certificate, < 27 if school certificate,

  • History of vertigo,

  • Claustrophobia,

  • Visual deficit not compatible with the use of the virtual reality mask,

  • Contraindication to surgery,

  • Outpatient treatment,

  • Refusal or inability to consent.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Monitoring of the device
Phase:
Study Start date:
May 24, 2022
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Pr SEIZEUR Romuald

    Brest,
    France

    Active - Recruiting

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