NCT06759389招募中不适用
The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation
CoLabs Medical2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ability to provide oxygenation during CPR
研究概览
简要总结
To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during cardiopulmonary resuscitation (CPR) and respiratory arrests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years, inclusive
- •IHCA (non-traumatic)
- •At least 4 feet in height
排除标准
- •Intubated with an endotracheal tube (ET)
- •Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
- •LAR or Family member objects to enrollment
- •Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
- •Responsive with an intact gag reflex
- •Blunt, penetrating, or burn-related injury, drowning, or electrocution
- •Known upper airway foreign body or mass
- •Lower airway obstruction
- •Dental gap of < 2 cm
- •Ingested caustic substances
- •Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician.
- •Known esophageal disease or facial/perforating neck trauma defined as study candidates with the following medical history:
- •Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures)
- •Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil)
- •Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood)
- •Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia)
- •History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation
结局指标
主要结局
Ability to provide oxygenation during CPR
时间窗: From device insertion through 1 hour
As measured through the monitoring of intra-arrest cerebral oximetry
Ability to provide ventilation during CPR
时间窗: From device insertion through 1 hour
As measured through the monitoring of intra-arrest PaCO2
Number of participants with device-related adverse events
时间窗: From device insertion through 3 months
Number and rate of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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