Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RVI-ERS
Brief Summary:
A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patients 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
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
Detailed Description:
A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patients 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 01 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 01 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
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 01 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 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None