Post Market Clinical Study of Skanrays Anesthetic Workstations - SkanSiesta Pro
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessing the adequate patient oxygenation,ventilation and delivery of anesthetic gas mixtures in accordance with need of the subjectsthroughout the surgery. Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition. Determine the possible unknown adverse events,undesirable side effects associated with use of the device.
研究概览
简要总结
Skanrays Anesthetic Workstations are continous use anesthetic workstations which are used to deliver anesthesia and provide mechanically or spontaneously induced ventilation to the adult and pediatric patients. It is capable of providing air oxygen N2O as mixture with anesthetic agents at set parameters. The purpose of this study is to confirm the clinical safety and performance of Skanrays anesthetic workstations. This study will generate the clinical evidence to support the claimed intended use.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender.The subjects belongs to the category of ASA1 physical status shall be included.
- •(Note: ASA2 ASA3 ASA4 and ASA5 classified physical status subjects shall be included after the completion of the pilot phase).Subject or the legally authorized representative on behalf of the subject shall be capable of understanding and signing the informed consent form.
排除标准
- •Subjects with age less than two year or less than 10 kg of body weight.Pregnant population shall be excluded.
结局指标
主要结局
Assessing the adequate patient oxygenation,ventilation and delivery of anesthetic gas mixtures in accordance with need of the subjectsthroughout the surgery. Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition. Determine the possible unknown adverse events,undesirable side effects associated with use of the device.
时间窗: For 60 minutes surgery: 0,12,24,36,48,60th | minute. | For 120 minutes surgery: 0,24,48,72,96,120th | minute. | For 360 minutes surgery: 0, 36,72,108,144,180 | minute.
次要结局
- Assessing the patient reported outcomes from user,collection of feedback from user and investigator(7days)
研究者
Dr VY Srinivas
Krishna Rajendra Hospital, Mysore