Sensory and Emotional Modulation of Dyspnea Under Artificial Ventilation in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Detection and quantification of dyspnea intensity change
研究概览
简要总结
Rationale: Half of the patients receiving mechanical ventilation in the intensive care unit (ICU) have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patients' comfort and could be involved in the genesis of post-traumatic stress syndromes, a frequent complication of intensive care. Modifying ventilation parameters does not always relieve dyspnea and administering morphine prolongs the duration of mechanical ventilation. Dyspnea has, in addition to its sensory component, an emotional component. The possibility to distract the patients' attention or to modulate their emotions in order to relieve their dyspnea could therefore represent an innovative therapeutic alternative devoid of side effects.
Objectives: To evaluate the effect of auditory and sensory extra respiratory stimuli on the sensation of dyspnea in intensive care patients undergoing mechanical, invasive or non-invasive ventilation.
Methods: 45 intensive care patients under artificial ventilation will be exposed, according to their randomization arm, to the following two stimuli for a duration of 10 minutes:
- standard relaxing music piece versus "pink" noise;
- fresh air on the face versus fresh air on the thigh. The effect of this stimulus will be compared to a randomized control, these two conditions will be separated by a wash-out period.
An pressure support (+5) increment will be performed to ensure comparability of subsequent experimental sequences and their effect on dyspnea.
Dyspnea will be assessed in terms of intensity (visual analog scale) and characterized sensorially. Will also be evaluated during the different conditions: pain, anxiety and stress (sympathetic/parasympathetic balance) and extra-diaphragmatic electromyographic activity.
Ethical framework: research involving the human person at risk and minimal constraints (physiology study that does not entail any risk for the patients).
Expected results and prospects: the investigators hypothesize that pleasant extra-respiratory sensory stimulation significantly reduces the intensity of dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention. This reduction in dyspnea is associated with decreased anxiety and stress levels.
This study will bring new, easy-to-use and side-effect-free tools to the therapeutic arsenal for the relief of dyspnea in mechanically ventilated patients.
详细描述
Dyspnea or "shortness of breath" is a major symptom that alters the quality of life of patients who suffer from it. It is a multimodal sensation that integrates psychological, social and environmental factors (1). Recent studies have shown that dyspnea and pain share a number of characteristics (2). In intensive care, dyspnea affects up to half of the patients under mechanical ventilation (3). However, unlike pain, which has been the subject of numerous studies in intensive care, relieving it is not a usual therapeutic objective.
In recent years, despite considerable progress in the understanding of the mechanisms of dyspnea, there has been no major advance in the therapeutic tools aimed at relieving it. The best evaluated and most prescribed drugs currently available to relieve dyspnea are morphine drugs (4). However, there is no formal proof of their long-term effectiveness and side effects such as the respiratory depressant effect make them difficult to use. Non-pharmacological tools integrating the sensory but also emotional dimension of dyspnea have also been developed. The investigators find parallel medicines (acupuncture, hypnosis...) but also extra respiratory stimulation techniques (thoracic vibrations, administration of fresh air to the face...) which modulate and relieve dyspnea with a certain success (1).
Optimizing tools to relieve dyspnea patients is therefore a priority. To date, the pharmacological arsenal is limited due to the number of effective molecules and their side effects. Non-pharmacological tools allowing to modulate the sensory and emotional components of dyspnea represent a therapeutic alternative that deserves to be explored. This is the purpose of this project.
Half of the patients undergoing mechanical ventilation in intensive care have moderate to severe dyspnea. This dyspnea has a negative impact on the duration of mechanical ventilation, on patient comfort and on the incidence of post-traumatic stress disorder. Changing ventilation parameters does not always relieve dyspnea, and administering morphine prolongs the duration of mechanical ventilation. The possibility of distracting the patients' attention or modulating their emotions in order to relieve their dyspnea seems to be a simple way to improve their comfort and could represent an innovative therapeutic alternative.
In this context, the investigators hypothesize that pleasant extra respiratory sensory stimulation relieves dyspnea in artificially ventilated patients without any change in ventilator settings and pharmacological intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical ventilation : invasive for at least 48 hours or non-invasive for at least 24 hours, sequential or continuous
- •Dyspnea ≥ 4 on a visual analogic scale (VAS) from 0 to 10
- •Absence of delirium (evaluated by the CAM-ICU score) ;
- •Communicative patient
排除标准
- •Patients on ECMO or decarboxylation ;
- •Patients on long-term left ventricular support;
- •Patients postoperatively following any surgery (pain from the procedure may interfere with dyspnea);
- •Protected minors and adults;
- •Pregnant women.
结局指标
主要结局
Detection and quantification of dyspnea intensity change
时间窗: At the baseline and during the interventions
Dyspnea will initially be searched for with absence or presence. If present, it will then be quantified using a visual analog scale graduated from 0 ("absence of respiratory discomfort") to 10 ("maximum respiratory discomfort").
次要结局
- Anxiety(At the baseline and during the interventions)
- Mesure of pain(At the baseline and during the interventions)
- Electromyogram of extra-diaphragmatic inspiratory muscles(At the baseline and during the interventions)