Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With Successfully Placed EASI Lines
研究概览
简要总结
Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).
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
- 是
入选标准
- •Subjects will be at least 18 years of age and have none of the following conditions:
- •pregnancy (negative urine pregnancy test to be performed before study participation),
- •diabetes, or coagulopathic (including taking any anticoagulants);
- •Subjects cannot be taking steroids or other immunosuppressants.
- •Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations.
- •Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.
排除标准
- 未提供
研究组 & 干预措施
EASI
Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.)
干预措施: Human recombinant hyaluronidase (HRH) (Drug)
EASI
Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.)
干预措施: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement (Procedure)
结局指标
主要结局
Number of Participants With Successfully Placed EASI Lines
时间窗: 1 day
Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose
时间窗: 1 day
Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.
次要结局
- Number of Participants With Pain During EASI Infusion(1 day)
- Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up(2 days)