Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit.

Study acronym: RVI-ERS
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated July 3, 2025 (before its estimated October 3, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Notable Start date: Oct 3, 2024 to Oct 3, 2025v4
  3. Notable Start date: Jun 25, 2024 to Oct 3, 2024
    • Primary and study completion dates: Jun 25, 2025 to Oct 3, 2025
    v3
  4. Minor Secondary endpoints revised (5)v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator. This test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3. Similarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms. Dyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care. The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support. The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the weaning trial. The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials. These benefits could be associated to a reduction in ventilatory drive. To assess dyspnea a VAS scale will be used, as the MV-RDOS scale, and the amplitude of EMG activity of inspiratory muscles.
Trial Details
NCT Number NCT06434116
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Spontaneous Breathing Trial in ICU
Related terms Anxiety Disorders, Dyspnea
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov