A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Staff interactions
研究概览
简要总结
To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically:
- Number, type and duration of staff interactions.
- Regulating and controlling ICP and CSF drainage.
- Maintaining system control with patient movement.
详细描述
In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF
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
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
- •GCS > 13 (minimum of E3V5M5) prior to study treatment.
- •Subject must be scheduled to have an EVD placed as part of routine management and for a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of hydrocephalus)
- •Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory Rate and weight assessed as not clinically significant (NCS) and afebrile as per PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment with the SED on Day 2)
- •Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
- •Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
- •Able to stand
- •Able to obtain consent
排除标准
- •Refractory ICP or needing active ICP management
- •Unable to tolerate brief clamping of EVD (<5min)
- •Unable to follow simple commands
- •Unconscious
- •Anticoagulant Therapy
- •Known bleeding diathesis
- •Scalp Infection
- •In the opinion of the Investigator the subject is not a good study candidate
研究组 & 干预措施
Single Arm study
Single Arm study In this study, the subject will act as their own control. On Day 1 of the two day study, the subject will be observed while treated on their standard EVD. On Day 2, the subject will be treated with the Smart External Drain (SED).
干预措施: Smart External Drain - SED (Device)
结局指标
主要结局
Staff interactions
时间窗: Two Days
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
次要结局
- Staff Time(Two Days)
- Safety(Two Days)