Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Occurence of acute chest syndrome
研究概览
简要总结
Acute chest syndrome is a severe respiratory complication of sickle cell disease.
The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.
Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.
详细描述
Acute chest syndrome is a severe complication of sickle cell disease. Several factors can contribute to this complication including infections, vaso-occlusive crisis, important pain that may give shortness of breath and morphinic treatments as they may cause hypoventilation.
The standard prevention of this dangerous complication is incentive spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
In patients who have had surgery who have also pain and morphinic treatments, non invasive ventilation have proven a good option for preventing pulmonary complications.
Besides, our experience in non invasive ventilation for treatment of acute chest syndrome show a good tolerance and efficiency. It also seems to help with pain management.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than incentive spirometry and may improve pain and quality of sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with SS or S-Beta sickle cell disease aged more than 6 years old and less then 20 years old
- •Hospitalised since less then 24 hours for severe vaso-occlusive crisis (either peripheric localisation or thoracic crisis) with morphinic requirements according to local pain management protocol
- •With a signed informed consent from the patient or his legal representative if the patient is under 18 years old
- •Benefiting of the French social security system
排除标准
- •Patient that has already participated in the study
- •Oxygen requirements, pneumonia, acute chest syndrome or other condition necessitating non invasive ventilation on admission
- •No understanding of spirometry or ventilation techniques
- •Other condition that forbid the use of non invasive ventilation or spirometry as defined by french consensus conference (2006) on non invasive ventilation
研究组 & 干预措施
Spirometry
Spirometry
干预措施: Spirometry (Device)
Non invasive positive pressure ventilation
Non invasive positive pressure ventilation
干预措施: Non invasive positive pressure ventilation (Device)
结局指标
主要结局
Occurence of acute chest syndrome
时间窗: up to 2 months at maximum (duration of hospitalization)
次要结局
- Pain(up to 2 months at maximum (duration of hospitalization))
- Morphinic requirements(up to 2 months at maximum (duration of hospitalization))
- Length of hospital stay(up to 2 months at maximum (duration of hospitalization))
- Comfort(up to 2 months at maximum (duration of hospitalization))
- Quality of sleep(up to 2 months at maximum (duration of hospitalization))