Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study

Официальное название

Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study / Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison

Обзор

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

Вмешательства

• Препарат OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
  In addition to standard intensive care management, patients will receive a hyperbaric oxygen therapy session within eight hours of admission to intensive care (the hyperbaric oxygen therapy session lasts two hours and must be completed eight hours after the hanging attempt).

Первичные конечные точки

• Montreal Cognitive Assessment Score [Срок оценки: 72 hours plus or minus 6 hours]

Вторичные конечные точки (4)

• Montreal Cognitive Assessment Score [Срок оценки: Montreal Cognitive Assessment Score at 6 months]
• Duration of mechanical ventilation [Срок оценки: 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 [Срок оценки: Participants will be monitored for duration of hospital stay, an expected average of 4 days.]
• Number of adverse events [Срок оценки: Number of adverse effects during hospitalization, an expected average of 4 days.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07461272 · 2025/0204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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