Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics
Condition: Vascular Access Device Complications
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Long Peripheral Catheter; Peripherally Inserted Central Catheter
Intervention type(s): Device; Device
Intervention description(s): Bard Powerglide 8 cm midline catheter; Bard 3fr, 4fr or 6fr; Cook 4fr; or Medcomp 1.9fr and 2.6fr
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: peripherally inserted central catheters, long peripheral catheters