Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study / Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Montreal Cognitive Assessment Score
研究概览
简要总结
During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. The main objective of the study is to evaluate in patients who have attempted hanging without presenting cardio-respiratory arrest, the effect of one Hyperbaric Oxygen therapy session in addition to standard intensive care management on a potential reduction in short-term neurological sequelae. Patients will benefit from either standard management or standard management associated with one Hyperbaric Oxygen therapy session
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients who present, following an attempted hanging, neurological distress defined by the presence of one or more of the following criteria:
- •Glasgow score < 13/15
- •Confusional syndrome
- •Psychomotor agitation Who most of the time require optimal neuroprotection by sedation and invasive mechanical ventilation for the purpose of protecting the airways.
- •Patient aged over 18 years,
- •Suicide attempt by hanging without cardiocirculatory arrest,
- •Patient insured socially and able to understand the information provided
排除标准
- •Response time exceeded by > 6 hours from the hanging
- •Attempted hanging with immediate return to normal consciousness
- •Refusal of consent from the family or trusted person at the time of inclusion in the study,
- •Patients and/or families unable to understand the information provided
研究组 & 干预措施
- Oxygèn
Patients will receive standard intensive care management and an oxygen therapy session within 8 hours
干预措施: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL (Drug)
- Control group
Patients will receive standard intensive care management only.
结局指标
主要结局
Montreal Cognitive Assessment Score
时间窗: 72 hours plus or minus 6 hours
The score can be interpreted as follows: ≥ 26/30 = no neurocognitive impairment 18-25/30 = mild impairment 10-17 = moderate impairment Less than 10 = severe impairment
次要结局
- Montreal Cognitive Assessment Score(Montreal Cognitive Assessment Score at 6 months)
- Duration of mechanical ventilation(Participants will be monitored for duration of mechanical ventilation Participants will be monitored for duration of mechanical ventilation, an expected average of 24 hours)
- Duration of hospital stay(Participants will be monitored for duration of hospital stay, an expected average of 4 days.)
- Number of adverse events(Number of adverse effects during hospitalization, an expected average of 4 days.)