Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.
研究概览
简要总结
To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.
详细描述
This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time.
The device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient undergoing a painful office procedure or exam
排除标准
- •Women that are Pregnant
- •Children under three years of age
研究组 & 干预措施
Hand Held NitrousTM
There are no other interventions to this device
干预措施: There are no other inteventions. (Other)
结局指标
主要结局
This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.
时间窗: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.
This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes).
次要结局
未报告次要终点
研究者
Mark Aldana
President
Strata Medical Innovations