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

NCT06434116 | Not Yet Recruiting

• 1 other identifier: APHP240431
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spontaneous Breathing Trial in ICU

Keywords

Spontaneous breathing trial; dyspnea; virtual reality; anxiety

Outcome Measures

Primary Outcomes (1)

• Respiratory discomfort VAS

  The primary endpoint is the comparison of the respiratory discomfort VAS between the intervention group (VR) and the control group (standard care) at the end of the ventilatory weaning test. Scale values:0-10, higher scores mean a worse outcome.

  At inclusion (day1)

Secondary Outcomes (5)

• Effect of IVR on anxiety intensity at the end of the withdrawal test

  At inclusion (day1)

• Evaluation of the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS (Mechanical Ventilation-Respiratory Distress Observation) score

  At inclusion (day1)

• Evaluation of the effect of virtual reality on respiratory drive assessed by the P 0.1, and EMG of scalene and parasternal muscle

  At inclusion (day1)

• Description of the effect of virtual reality on respiratory rate and heart rate

  At inclusion (day1)

• Evaluation of the tolerance of virtual reality.

  At inclusion (day1)

Study Arms (2)

Immersive virtual reality in patient with VAS dyspnea ≥ 3

EXPERIMENTAL

Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period). A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care). The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation.

Device: Immersive virtual reality

Control in patient with VAS dyspnea ≥ 3

EXPERIMENTAL

Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period). A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care). The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation.

Device: Immersive virtual reality

Interventions

Immersive virtual reality DEVICE

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. Virtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G / Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection.

Control in patient with VAS dyspnea ≥ 3; Immersive virtual reality in patient with VAS dyspnea ≥ 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients intubated and on mechanical ventilation for more than 24 hours
• Patients eligible for a weaning trial (resolution of acute phase of pathology, low bronchial congestion, effective cough, SpO2 \> 90% with Fio2 \< 40%, PEEP \< 8 cmH20, respiratory rate \< 40/min, haemodynamically stable)
• Decision by the doctor in charge to initiate a respiratory weaning trial as part of treatment
• RASS score between -1 and +1
• Patient able to answer questionnaires
• Informed of the study and whose free and informed written consent has been obtained
• Beneficiary of a social security plan (excluding AME)

You may not qualify if:

• Non french speaker
• Acute confusion or cognitive disorders
• No reliable assessment of dyspnea
• Acrophobia
• Claustrophobia
• Photophobia
• Hearing loss
• Visual impairment
• Subject under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Dyspnea; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Capucine MORELOT-PANZINI, MD,PHD

CONTACT

+33 1 42 16 78 59; capucine.morelot@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: October 3, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: July 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal