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Spontaneous Breathing Trial in ICURVI-ERSNCT06434116

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

A study testing Immersive virtual reality in people with Spontaneous Breathing Trial in ICU, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Breathing Trial in ICU
What is being tested?
Immersive virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
3 Oct 2025to 3 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Non french speaker
  • Acute confusion or cognitive disorders
  • No reliable assessment of dyspnea
  • Acrophobia
  • Claustrophobia
  • Photophobia
Show all 9Show fewer
  • Hearing loss
  • Visual impairment
  • Subject under guardianship or curatorship

Trial locations and contacts

No sites are listed yet.

Capucine MORELOT-PANZINI, MD,PHD contact

+33 1 42 16 78 59

capucine.morelot@aphp.fr

About this study

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

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.

Read more

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.

Read the detailed description

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.

Dyspnea exposes patients to the risk of neuropsychological sequel, in particular the occurrence of post-traumatic stress.

Dyspnea is define by the ATS as "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity " . It represents a conscious and distressing sensation of breathing difficulty. It is characterized by its multidimensional aspect with a sensory and affective dimension.

To assess dyspnea a VAS scale will be used, the MV-RDOS scale, which is a recently developed tool for the hetero-assessment of dyspnea in intubated patients. The amplitude of EMG activity of the extradiaphragmatic inspiratory muscles is proportional to the intensity of dyspnea and reflects the intensity of ventilatory command. The activity of the parasternal and scalene muscles can be collected using surface electrodes.

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.

Several studies have shown that medical hypnosis can improve the sensory and affective components of pain, and also appears to have a beneficial effect on the management of dyspnea and anxiety.

Numerous studies have shown that the use of virtual reality reduces the intensity of acute and chronic pain. Several studies have also shown that immersive virtual reality helps to reduce anxiety associated with medical procedures. A study has also found that the use of virtual reality in patients hospitalized with acute SARS-CoV-2 infection improves dyspnea, anxiety, well-being and fatigue.

The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the trial.

The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials.

This will be an open label, monocentric, randomized controlled study in the intensive care unit of PItié-Salpêtrière hospital. Patient will be recruited if they are undergoing a spontaneous breathing trial as part of their usual care.

The main objective is to measure the effect of virtual reality during a ventilatory weaning trial in comparison with current practice on respiratory discomfort. Respiratory discomfort will be assessed using a visual analogue scale at the end of the ventilatory weaning trial.

The secondary objectives are to evaluate the effect of virtual reality on the intensity of anxiety, to evaluate the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS score, to evaluate the effect of virtual reality on ventilatory drive assessed by the P 0.1 and EMG of scalene and parasternal muscle , to describe the effect of virtual reality on respiratory rate and heart rate, and to evaluate tolerance of virtual reality.

The study will be conducted as follows:

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 care, with one of the two interventions according to randomisation.

Patients with a VAS <3 cm after the first weaning trial will not be randomised. In line with standard care, a second weaning test lasting a further 15 minutes will also be performed without intervention.

Throughout the study, the investigator will record clinical and functional data. EMG monitoring of the paraspinal and scalene muscles will be carried out throughout the test. Similarly, P 0.1 will be monitored at the beginning and end of the weaning test. The respiratory discomfort VAS, the MV-RDOS and the anxiety VAS will be assessed at the end of the weaning trial.

Completion of the sickness simulator questionnaire after the use of virtual reality in order to assess tolerance.

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."

Being tested
Immersive virtual reality
Keywords
Spontaneous breathing trial, dyspnea, virtual reality, anxiety
Medical subject headings
Dyspnea, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive virtual realityDevice

    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.

Study groups in NCT06434116
Study groupRoleWhat they receive
Immersive virtual reality in patient with VAS dyspnea ≥ 3ExperimentalOnce 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.
Receives: Device: Immersive virtual reality
Control in patient with VAS dyspnea ≥ 3ExperimentalOnce 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.
Receives: Device: Immersive virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At inclusion (day1)

Secondary outcomes (5)
  1. Effect of IVR on anxiety intensity at the end of the withdrawal test

    Comparison of the VAS anxiety at the end of the weaning trial between the VR group and the control group Scale values:0-10, higher scores mean a worse outcome.

    Measured: At inclusion (day1)

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

    Comparison of the MV-RDOS scale between the VR group and the control group (Clinically important dyspenea is defined by MV-RDOS value ≥ 2.6)

    Measured: At inclusion (day1)

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

    Evolution of physiological measurements (RMS of the parasternal and scalene EMG, P 0.1) between the VR group and the control group

    Measured: At inclusion (day1)

  4. Description of the effect of virtual reality on respiratory rate and heart rate

    Evolution of physiological measurements (respiratory rate, heart rate) between the VR group and the control group

    Measured: At inclusion (day1)

  5. Evaluation of the tolerance of virtual reality.

    Measurement of tolerance by the simulator sickness questionnaire in the VR group.

    Measured: At inclusion (day1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start3 Oct 2025 (estimated)
  3. Primary completion3 Oct 2025 (estimated)
  4. Study completion3 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434116
Sponsor's protocol ID
APHP240431
Acronym
RVI-ERS
Status last verified
Sep 2024
First submitted
23 May 2024
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\&#39;informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

Questions about this trial

What is this clinical trial studying?

A study testing Immersive virtual reality in people with Spontaneous Breathing Trial in ICU, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Capucine MORELOT-PANZINI, MD,PHD (+33 1 42 16 78 59, capucine.morelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory discomfort VAS (time frame: At inclusion (day1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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