Procedural and Post-Procedural Clinical Performance of a Novel Peripheral Intravenous Needle Over Catheter Device (OspreyTM)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Attempts
研究概览
简要总结
Emergency Department Patients who were to get intravenous (IV) access through routine medical care will receive it through trademarked catheter via convenience sample. Patient and clinician experience, including adverse events, will be recorded. A standardized data entry sheet will be collected at time of enrollment, and then daily thereafter while the subject has the IV. The data collected will remain anonymous.
详细描述
Identification of Subjects:
The emergency department is a designated participating unit providing subjects with medical care that are anticipated to be placed in the observation unit or admitted to an inpatient unit. Subjects who meet inclusion criteria will be consented to be included in the study.
Assignment of Subject Identification Number:
A unique identification number will be given to study subjects. Subject numbers will be assigned in sequential order. The subject number will consist of 6 characters. The first three characters will designate the manufacturer-specific protocol number (SVI). The last three characters will designate the subject by number in sequential order.
Informed Consent:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Any gender, 18 years of age or older ii. Acceptable candidate for an elective PIV as determined by physician. iii. Anticipated admission to inpatient unit.
排除标准
- •Any gender, < 18 years old.
- •Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- •Previous venous grafts or surgery at the target vessel access site;
- •Currently involved in other investigational clinical trials (unless permission is granted by other study Pl)
- •Subjects who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating
结局指标
主要结局
Number of Attempts
时间窗: 10 minutes
The number of attempts that operator needs to access vein and secure device for proper bidirectional flow
次要结局
- Removal reason(1 week)
- Flushing characteristic(10 minutes)
- Time to removal(1 week)
- Patient discomfort(10 minutes)
- Site Pain(1 week)
- Blood culture contamination rates(1 week)
- Edema(1 week)
- Redness(1 week)
- Drainage(1 week)