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Vascular Access Device ComplicationsComPLETNCT05346406

Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics

A study testing Midline Catheter and Peripherally Inserted Central Catheter in people with Vascular Access Device Complications, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Vascular Access Device Complications
What is being tested?
Midline Catheter and Peripherally Inserted Central Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
10 Aug 2022to 10 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Midline Catheter, Peripherally Inserted Central Catheter
Keywords
peripherally inserted central catheters, long peripheral catheters

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Midline CatheterDevice

    Also called Long peripheral catheter

    Bard Powerglide 8 cm midline catheter

  • Peripherally Inserted Central CatheterDevice

    Bard 3fr, 4fr or 6fr; Cook 4fr; or Medcomp 1.9fr and 2.6fr

Study groups in NCT05346406
Study groupRoleWhat they receive
Peripherally Inserted Central Catheter, Randomized (PICC R)Active comparatorNot described
Receives: Device: Peripherally Inserted Central Catheter
Midline Catheter, Randomized (MC R)ExperimentalAlso known as long peripheral catheter (LPC)
Receives: Device: Midline Catheter
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)No interventionObservational only arm
Midline Catheter, Non-Randomized (MC NR)No interventionObservational only arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Eligible Patients That Agreed to Participate

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

    Measured: Day of enrollment

  2. 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).

    Measured: An average of 14 days

Secondary outcomes (5)
  1. Number of Participants Who Completed Therapy With Initial VAD

    percent of participants in each group that completed the therapy the VAD was requested for with original VAD

    Measured: An average of 14 days

  2. Number of Participants With at Least One 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

    Measured: An average of 14 days

  3. Number of Participants That Received Sedation for VAD Placement

    sedation completed (yes/no)

    Measured: 1 day (day of enrollment/VAD placement)

  4. Number of Participants With VAD Successfully Used for Blood Draws

    at least one successful blood draw (yes/no)

    Measured: An average of 14 days

  5. Number of Participants Requiring Additional VADs to Complete Therapy

    any additional VADs placed to complete therapy or supplement therapy

    Measured: An average of 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start10 Aug 2022
  3. Primary completion10 Aug 2023
  4. Study completion10 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05346406
Sponsor's protocol ID
MCW2022
Acronym
ComPLET
Status last verified
May 2025
First submitted
1 Apr 2022
Last updated
17 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Paterson RS, Chopra V, Brown E, Kleidon TM, Cooke M, Rickard CM, Bernstein SJ, Ullman AJ. Selection and Insertion of Vascular Access Devices in Pediatrics: A Systematic Review. Pediatrics. 2020 Jun;145(Suppl 3):S243-S268. doi: 10.1542/peds.2019-3474H.

    PubMed 32482738
  • Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.

    PubMed 26459655
  • Ullman AJ, Bernstein SJ, Brown E, Aiyagari R, Doellman D, Faustino EVS, Gore B, Jacobs JP, Jaffray J, Kleidon T, Mahajan PV, McBride CA, Morton K, Pitts S, Prentice E, Rivard DC, Shaughnessy E, Stranz M, Wolf J, Cooper DS, Cooke M, Rickard CM, Chopra V. The Michigan Appropriateness Guide for Intravenous Catheters in Pediatrics: miniMAGIC. Pediatrics. 2020 Jun;145(Suppl 3):S269-S284. doi: 10.1542/peds.2019-3474I.

    PubMed 32482739
  • Gibson C, Connolly BL, Moineddin R, Mahant S, Filipescu D, Amaral JG. Peripherally inserted central catheters: use at a tertiary care pediatric center. J Vasc Interv Radiol. 2013 Sep;24(9):1323-31. doi: 10.1016/j.jvir.2013.04.010. Epub 2013 Jul 19.

    PubMed 23876551
  • Burek AG, Parker J, Bentzien R, Talbert L, Havas M, Hanson SJ. The Development of a Long Peripheral Catheter Program at a Large Pediatric Academic Center: A Pilot Study. Hosp Pediatr. 2020 Oct;10(10):897-901. doi: 10.1542/hpeds.2020-0181.

    PubMed 32998934
  • Noonan PJ, Hanson SJ, Simpson PM, Dasgupta M, Petersen TL. Comparison of Complication Rates of Central Venous Catheters Versus Peripherally Inserted Central Venous Catheters in Pediatric Patients. Pediatr Crit Care Med. 2018 Dec;19(12):1097-1105. doi: 10.1097/PCC.0000000000001707.

    PubMed 30142121
  • Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.

    PubMed 27908432
  • Chenoweth KB, Guo JW, Chan B. The Extended Dwell Peripheral Intravenous Catheter Is an Alternative Method of NICU Intravenous Access. Adv Neonatal Care. 2018 Aug;18(4):295-301. doi: 10.1097/ANC.0000000000000515.

    PubMed 29847401
  • Kleidon TM, Schults JA, Wainwright C, Mihala G, Gibson V, Saiyed M, Byrnes J, Cattanach P, Macfarlane F, Graham N, Shevill E, Ullman AJ. Comparison of midline catheters and peripherally inserted central catheters to reduce the need for general anesthesia in children with respiratory disease: A feasibility randomized controlled trial. Paediatr Anaesth. 2021 Sep;31(9):985-995. doi: 10.1111/pan.14229. Epub 2021 Jun 21.

    PubMed 34053159
  • Qian SY, Horn MT, Barnes R, Armstrong D. The use of 8-cm 22G Seldinger catheters for intravenous access in children with cystic fibrosis. J Vasc Access. 2014 Sep-Oct;15(5):415-7. doi: 10.5301/jva.5000274. Epub 2014 Jul 4.

    PubMed 25041922
  • Pacilli M, Bradshaw CJ, Clarke SA. Use of 8-cm 22G-long peripheral cannulas in pediatric patients. J Vasc Access. 2018 Sep;19(5):496-500. doi: 10.1177/1129729818761278. Epub 2018 Mar 12.

    PubMed 29529968
  • Paladini A, Chiaretti A, Sellasie KW, Pittiruti M, Vento G. Ultrasound-guided placement of long peripheral cannulas in children over the age of 10 years admitted to the emergency department: a pilot study. BMJ Paediatr Open. 2018 Mar 28;2(1):e000244. doi: 10.1136/bmjpo-2017-000244. eCollection 2018.

    PubMed 29637197

Questions about this trial

What is this clinical trial studying?

A study testing Midline Catheter and Peripherally Inserted Central Catheter in people with Vascular Access Device Complications, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Eligible Patients That Agreed to Participate (time frame: Day of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346406, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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