A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Success of Initial IV Placement Attempt
研究概览
简要总结
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
详细描述
The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale. Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access. If randomized to ultrasound guided IV access, the IV will be placed under direct visualization. Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement. The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency department patients ages 0-18 years
- •Requiring IV access as determined by emergency department attending physician
- •Predicted difficult IV access as defined by a revised DIVA score >3
排除标准
- •Unstable patients triaged as a Level 1 triage acuity
- •Patients who refuse IV access
- •Non-English speaking parent/guardian
- •No study team member available to enroll patient
- •Parent/guardian does not consent
- •Allergy to ultrasound gel
研究组 & 干预措施
Ultrasound guided intravenous access
This group will have their IV placed by ultrasound guidance.
干预措施: Ultrasound guidance (Procedure)
Traditional intravenous access
The patients randomized to traditional IV access will have their IVs placed by standard technique.
干预措施: Traditional intravenous access (Procedure)
结局指标
主要结局
Success of Initial IV Placement Attempt
时间窗: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.
次要结局
- Measure the overall number of IV attempts..(Participants will be followed through the duration of emergency department stay, an expected average of 4 hours)
- Time to IV access.(Participants will be followed through the duration of emergency department stay, an expected average of 4 hours)
- Patient & family satisfaction with IV placement method.(Participants will be followed through the duration of emergency department stay, an expected average of 4 hours)
- Compare the survival (in length of time) of IV access(Participants will be followed through the duration of hospital stay, expected average of 5 days)