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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non french speaker

Acute confusion or cognitive disorders

No reliable assessment of dyspnea

Acrophobia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Immersive virtual reality in patient with VAS dyspnea ≥ 3Experimental treatment 1 intervention
Group B: Control in patient with VAS dyspnea ≥ 3Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
At inclusion (day1)

Secondary outcomes

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.

Time frame
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)

Time frame
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

Time frame
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

Time frame
At inclusion (day1)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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