Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
研究概览
简要总结
The goal of this Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The main aims are:
- The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely.
- The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied
Participants will be randomized to control and intervention group. Control group will be receiving treatment using manual drainage system while intervention group will be using Effidrain machine.
Participants and Nurses from both control and intervention group will be asked to fill participant/nurses questionnaire form respectively.
详细描述
The mission of the Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely.
The primary hypothesis is that the group of patients with device drainage intervention would be able to demonstrate actual fluid drainage not more than 110% of the physician-prescribed drainage volume and time.
The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pleural effusion or ascites as the primary indication for chest or abdominal drain insertion
- •Expected ascites drainage volume more than 1 Litre or at least moderate sized pleural effusion (occupying more than one-third hemi-thorax)
- •uncomplicated chest or abdominal drain insertion
- •Adults aged 21 years, able to provide (or surrogate able to provide) consent.
排除标准
- •Vulnerable persons, including but not limited to, pregnant women and prisoners
- •Hemodynamic instability, defined by heart rate more than 120 beats per minutes and blood pressure less than systolic 90mmHg
- •Haemothorax or Haemoperitoneum
- •pneumothorax or pneumoperitoneum
- •chest or abdominal drain insertion => 48 hours with more than estimated 50% of total body cavity fluid drained
结局指标
主要结局
demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
时间窗: after 72 hours of usage per patient
A session completed by the medical device not exceeding 10% volume of the physican precribed drainage volume is considered a success and scored as completely meeting device efficacy criteria. A session completed by the medical device not exceeding 25% volume of the physican precribed drainage volume is considered a success and scored as partially meeting device efficacy criteria. A session completed by the medical device exceeding 25% volume of the physican precribed drainage volume is considered a failure and scored as not meeting device efficacy criteria.
次要结局
- Reduction in time required for post-procedure monitoring by healthcare workers(after 72 hours of usage per patient)
- Reduction in time that a subject requires a chest or abdominal drain in-situ(Total of 4 hours for Pleural arm and 5 hours for Ascites arm)
- Improvement in cost-effectiveness of care for each inpatient episode of pleural effusion or ascites that requires drainage.(after 72 hours of usage per patient)
研究者
Jessica Quah Li Shan
Consultant
Changi General Hospital