Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Aim 2: To identify a population in which a LPC is a safe and effective alternative to a PICC for vascular access in hospitalized pediatric patients age > 2 years, in need of non-central, medium-term access. Hypothesis: LPCs are non-inferior to PICCs for delivery of peripherally compatible infusate needed for 5-14 days in hospitalized pediatric patients. The investigators plan to determine the time-to-removal of the VAD, both secondary to completion of therapy and secondary to complications. Safety will be assessed by measuring complication rate (e.g., VTE, CLABSI, occlusion, dislodgement, phlebitis). Aim 3: To engage patients and families as advisors in vascular access device selection. The investigators will describe the patient and family experience with device placement and maintenance as well as perceived patient and parent insertion-related and sedation-related distress. Mixed methods (quantitative and qualitative analysis) will be used for this aim. The results of this study will guide the design of a full-scale effectiveness clinical trial comparing PICCs and LPCs in pediatric patients that require medium-term, non-central venous access. The investigators will identify patient characteristics and clinical situations in which LPCs are safe and effective alternatives to PICCs, allowing us to take the next step to reduce PICC use and the associated complications. The family and patient experience with VADs will add essential information that will guide device selection and future research on patient-centered outcomes. Our work will add to ongoing efforts to improve health care quality and safety in pediatrics.

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

Conditions
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Vascular Access Device Complications

Intervention / Treatment
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* Device: Long Peripheral Catheter
* Device: Peripherally Inserted Central Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: non-English-speaking family active bacteremia or VTE at site where device would be placed urgent need of vascular access (within 4 hours)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peripherally Inserted Central Catheter<br> | Device: Peripherally Inserted Central Catheter<br>* Bard 3fr, 4fr or 6fr; Cook 4fr; or Medcomp 1.9fr and 2.6fr<br>|
| Experimental: Long Peripheral Catheter<br> | Device: Long Peripheral Catheter<br>* Bard Powerglide 8 cm midline catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of feasibility measures accomplished | The feasibility outcome is a composite of the four feasibility measures: (1) > 70% of eligible patients agree to enrollment and randomization, (2) > 80% of enrolled patients receive the assigned intervention, (3) > 80% of providers involved in insertion of the VADs find the study acceptable, and (4) < 5% of data for primary outcome is missing | Through the study completion, an average of 1 year | 
| Average dwell-time | Dwell-time will be measured using the time-to-device removal for all reasons (both secondary to completion of therapy and secondary to complications). | An average of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent completion of therapy with initial VAD | percent of participants in each group that completed the therapy the VAD was requested for with original VAD | An average of 14 days | 
| The composite rate of complications | the rate of any complications, including suspected VTE (ultrasound obtained), suspected CLABSI (blood culture obtained), confirmed VTE (ultrasound positive for clot), confirmed CLABSI (blood culture positive), dislodgement, occlusion, phlebitis, line dysfunction, infiltration, leaking | An average of 14 days | 
| Percent participants that received sedation for VAD placement | sedation completed (yes/no) | 1 day (day of enrollment/VAD placement) | 
| Percent participants with prolonged NPO (nothing by mouth) time | greater than 8 hours documented NPO time due to awaiting/expected sedation for VAD placement | 1 day | 
| Percent VADs successfully used for blood draws | at least one successful blood draw (yes/no), number of blood draws during length of catheter (both successful and unsuccessful) and time-to-last successful blood draw | An average of 14 days | 
| Average time-to-placement of VAD | time from PICC order placed to placement of VAD completion | 1 day | 
| Percent participants requiring additional VADs to complete therapy | any additional VADs placed to complete therapy or supplement therapy | An average of 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripherally inserted central catheters, long peripheral catheters