A prospective, cross sectional, open label, single arm, non-randomised clinical study to confirm clinical safety and performance of Skanray’s Anesthetic Workstations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determining the safety and performance in terms of delivered parameters against the intended or set values for the specific subject condition. The ventilatory, vital physiological and anesthesia gas monitoring parameters should be evaluated.
研究概览
简要总结
This clinical study aims to evaluate the safety and performance of Skanray Anesthetic Workstations in delivering precise oxygen-anesthetic gas mixtures and providing mechanical ventilation support during surgical procedures. The prospective, single arm study will assess whether the workstation meets its intended clinical use parameters for patients aged 2 years and above (equal or more than 10kg body weight). By documenting operational performance against set values and collecting user feedback, the study seeks to generate clinical evidence supporting the devices safety and performance in routine anesthesia practice. A total 15 subjects were enrolled in the pilot phase (NHMEC Ref no. S110/2022) the study was closed. The pilot phase report and closeout annexure were submitted. following an upgrade in the Skanray anesthetic workstation a new study was initiated and registered under CTRI/2025/02/081197 on 24 February 2025
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.
- •Subject or the legally authorised 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.
结局指标
主要结局
Determining the safety and performance in terms of delivered parameters against the intended or set values for the specific subject condition. The ventilatory, vital physiological and anesthesia gas monitoring parameters should be evaluated.
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
- Collection of feedback from the user /investigator reflecting the ease of delivering the anesthetic gas mixture, ventilatory support and usability.(Collection of feedback which includes the investigators assessment of the overall safety and performance of the Skanray’s Anesthetic Workstations.)