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临床试验/NCT05346406
NCT05346406已完成不适用

Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters for Non-central Vascular Access Indications - a Clinical Effectiveness Pilot Trial in Pediatrics

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Percent Eligible Patients That Agreed to Participate

研究概览

简要总结

Peripherally Inserted Central Catheters (PICCs) are frequently used in hospitalized children who require prolonged vascular access; however, concerns regarding their inappropriate use and contribution to serious complications such as central line associated blood stream infection (CLABSI) and venous thromboembolism (VTE) have triggered exploration of safer alternatives. Long Peripheral Catheters (LPCs) have been recently adopted by some institutions due to fewer complications as compared to PICCs. The investigators hypothesize that LPCs could be safer alternatives to PICCs for medium-term vascular access (5-14 days) in the appropriate cohort of hospitalized pediatric patients. The primary objective of the proposed clinical effectiveness pilot trial is to test the feasibility of a full-scale effectiveness trial comparing PICCs to LPCs in hospitalized pediatric patients. The investigators aim to identify a population in which LPCs are safe and effective alternatives to PICCs for medium-term, non-central vascular access; data that will inform the design of a full-scale effectiveness study. The investigators plan to engage patients and families as advisors in vascular access device selection by understanding their experience with vascular access device placement and maintenance. Over time, use of LPCs should result in decreased inappropriate PICC utilization with a concomitant decrease in serious complications such as CLABSI and VTE.

详细描述

Hospitalized children frequently require a vascular access device (VAD) for delivery of life saving interventions such as intravenous fluids and antibiotics. Peripherally Inserted Central Catheters (PICCs) are central VADs frequently used in hospitalized children for prolonged vascular access, or to administer solutions not compatible with peripheral infusion. However, PICC related complications such as venous thromboembolism (VTE) and central line associated blood stream infections (CLABSI) have triggered exploration of safer alternatives. Long Peripheral Catheters (LPCs) are peripheral VADs recently adopted for medium-term vascular access (5-14 days) and peripherally compatible infusate, due to potential for fewer complications compared to PICCs. However, there is a scarcity of literature on the effective and safe use of LPCs in pediatrics. To reduce the use of PICCs when central venous access is not required (i.e., infusate is peripherally compatible), feasible alternatives for vascular access need to be identified and tested. Until clinicians and other stakeholders are given effective alternatives for durable vascular access and evidence-based tools for VAD selection, central VAD related complications will remain a critical concern, placing children at risk for harm and increasing healthcare costs.

The overall objective of this application is to test the feasibility of a full-scale effectiveness trial comparing PICCs to LPCs and identify a population in which a LPC would be a safe and effective alternative to a PICC. In a prior study, our group showed that as many as 139 PICCs over a one-year period were placed at our local institution in children that (1) did not require central venous access for administration of peripherally incompatible infusate, (2) had the VAD in for < 14 days, and (3) did not discharge home with the VAD, but because of PICC placement for vascular access these children were at risk for CLABSI and VTE. The pediatric population satisfying the above conditions is the target of our pilot trial. A LPC program was introduced at our local institution in 2019 with initiation in the intensive care units and plans to expand the program to the whole hospital by the fall of 2021. In our initial group of 20 successfully placed LPCs, there were no severe complications (VTE and CLABSI).

The aims of this pilot, randomized controlled trial are:

Aim 1: To assess the feasibility of a full-scale effectiveness trial comparing PICCs to LPCs in hospitalized pediatric patients in need of non-central, medium-term vascular access (5-14 days anticipated need).

Hypothesis: Feasibility of a full-scale effectiveness trial will be established by demonstrating that > 70% of eligible patients agree to enrollment and randomization, > 80% of randomized patients receive the assigned intervention, > 80% of providers involved find the study acceptable, and < 5% of data are missing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients age 2 to 17 years admitted to Children's Wisconsin and requesting placement of a PICC for:
  • anticipated length of intravenous treatment of 5-14 days AND
  • peripherally compatible infusate AND
  • VAD not needed at discharge

排除标准

  • non-English-speaking family
  • active bacteremia or VTE at site where device would be placed
  • urgent need of vascular access (within 4 hours)

研究组 & 干预措施

Peripherally Inserted Central Catheter, Randomized (PICC R)

Active Comparator

干预措施: Peripherally Inserted Central Catheter (Device)

Midline Catheter, Randomized (MC R)

Experimental

Also known as long peripheral catheter (LPC)

干预措施: Midline Catheter (Device)

Peripherally Inserted Central Catheter, Non-randomized (PICC NR)

No Intervention

Observational only arm

Midline Catheter, Non-Randomized (MC NR)

No Intervention

Observational only arm

结局指标

主要结局

Percent Eligible Patients That Agreed to Participate

时间窗: Day of enrollment

Percent eligible patients that agreed to participate in the randomized part of the study

Average Dwell-time

时间窗: An average of 14 days

Dwell-time will be measured using the time-to-device removal for all reasons (both secondary to completion of therapy and secondary to complications).

次要结局

  • Number of Participants That Received Sedation for VAD Placement(1 day (day of enrollment/VAD placement))
  • Number of Participants With VAD Successfully Used for Blood Draws(An average of 14 days)
  • Number of Participants Requiring Additional VADs to Complete Therapy(An average of 14 days)
  • Number of Participants Who Completed Therapy With Initial VAD(An average of 14 days)
  • Number of Participants With at Least One Complications(An average of 14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alina Burek

Assistant Professor

Medical College of Wisconsin

研究点 (1)

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