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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Immersive virtual reality
DeviceThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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)
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
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
Locations
Sponsors and contacts
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