Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics (ComPLET)

September 15, 2023 updated by: Alina Burek, Medical College of Wisconsin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients age 2 to 17 years admitted to Children's Wisconsin and requesting placement of a PICC for:

    1. anticipated length of intravenous treatment of 5-14 days AND
    2. peripherally compatible infusate AND
    3. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of feasibility measures accomplished
Time Frame: Through the study completion, an average of 1 year
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
Time Frame: 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).
An average of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent completion of therapy with initial VAD
Time Frame: An average of 14 days
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
Time Frame: An average of 14 days
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
Time Frame: 1 day (day of enrollment/VAD placement)
sedation completed (yes/no)
1 day (day of enrollment/VAD placement)
Percent participants with prolonged NPO (nothing by mouth) time
Time Frame: 1 day
greater than 8 hours documented NPO time due to awaiting/expected sedation for VAD placement
1 day
Percent VADs successfully used for blood draws
Time Frame: An average of 14 days
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 Frame: 1 day
time from PICC order placed to placement of VAD completion
1 day
Percent participants requiring additional VADs to complete therapy
Time Frame: An average of 14 days
any additional VADs placed to complete therapy or supplement therapy
An average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Alina Burek, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCW2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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