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Comparing Peripherally Inserted Central Catheters to Long Peripheral Catheters in Pediatrics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05346406
Acronym
ComPLET
Enrollment
35
Registered
2022-04-26
Start date
2022-08-10
Completion date
2023-08-10
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access Device Complications

Keywords

peripherally inserted central catheters, long peripheral catheters

Brief 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.

Interventions

DEVICEMidline Catheter

Bard Powerglide 8 cm midline catheter

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Percent Eligible Patients That Agreed to ParticipateDay of enrollmentPercent eligible patients that agreed to participate in the randomized part of the study
Average Dwell-timeAn average of 14 daysDwell-time will be measured using the time-to-device removal for all reasons (both secondary to completion of therapy and secondary to complications).

Secondary

MeasureTime frameDescription
Number of Participants That Received Sedation for VAD Placement1 day (day of enrollment/VAD placement)sedation completed (yes/no)
Number of Participants Who Completed Therapy With Initial VADAn average of 14 dayspercent of participants in each group that completed the therapy the VAD was requested for with original VAD
Number of Participants Requiring Additional VADs to Complete TherapyAn average of 14 daysany additional VADs placed to complete therapy or supplement therapy
Number of Participants With VAD Successfully Used for Blood DrawsAn average of 14 daysat least one successful blood draw (yes/no)
Number of Participants With at Least One ComplicationsAn average of 14 daysthe 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

Countries

United States

Participant flow

Pre-assignment details

We had an enrollment goal of 30 participants per each randomized arm. The RCT eligibility was not met.

Participants by arm

ArmCount
Peripherally Inserted Central Catheter, Randomized (PICC R)
PICC randomized arm: An uncoated polyurethane PICC with an external clamp was placed in the upper arm, and the available sizes were 3 to 6Fr (Bard, Becton Dickinson). The catheter type and size were selected based on IR standard protocol.
4
Midline Catheter, Randomized (MC R)
MC randomized arm: An uncoated MC with available sizes of 8 cm, 20 to 22G (Powerglide, Becton Dickinson). The catheter size was selected by an inserter based on patient size. All MCs were placed in the upper arm with the tip of the catheter ending at or below the axilla
4
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
PICC non-randomized arm - observational only
6
Midline Catheter, Non-randomized (MC NR)
MC non-randomized arm -observational only
21
Total35

Baseline characteristics

CharacteristicTotalMidline Catheter, Randomized (MC R)Midline Catheter, Non-randomized (MC NR)Peripherally Inserted Central Catheter, Randomized (PICC R)Peripherally Inserted Central Catheter, Non-randomized (PICC NR)
Age, Continuous9.8 years10.8 years11.2 years10.2 years8.4 years
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants2 Participants2 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants2 Participants19 Participants3 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants1 Participants0 Participants
Primary Diagnosis
Medical
17 Participants4 Participants5 Participants4 Participants4 Participants
Primary Diagnosis
Surgical
18 Participants0 Participants16 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
29 Participants3 Participants17 Participants3 Participants6 Participants
Severity/Location
Acute care
25 Participants4 Participants11 Participants4 Participants6 Participants
Severity/Location
Critical care
10 Participants0 Participants10 Participants0 Participants0 Participants
Sex: Female, Male
Female
15 Participants0 Participants9 Participants4 Participants2 Participants
Sex: Female, Male
Male
20 Participants4 Participants12 Participants0 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 40 / 60 / 21
other
Total, other adverse events
0 / 42 / 40 / 65 / 21
serious
Total, serious adverse events
0 / 40 / 40 / 60 / 21

Outcome results

Primary

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).

Time frame: An average of 14 days

ArmMeasureValue (MEDIAN)
Eligible ParticipantsAverage Dwell-time11.0 days
Midline Catheter, Randomized (PICC R)Average Dwell-time4.7 days
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Average Dwell-time8.5 days
Midline Catheter, Non-randomized (MC NR)Average Dwell-time8.0 days
Primary

Percent Eligible Patients That Agreed to Participate

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

Time frame: Day of enrollment

Population: The primary outcome, a feasibility outcome, only applied to the randomized portion of the study (PICC R and MC R arms); and is the proportion of patients that agreed to participate in randomization out of all eligible patients. Therefore, the Overall Number of Participants Analyzed represents the number of participants eligible for the randomization part of the study prior to enrollment.

ArmMeasureValue (NUMBER)
Eligible ParticipantsPercent Eligible Patients That Agreed to Participate80 percentage of eligible patients agreed t
Secondary

Number of Participants Requiring Additional VADs to Complete Therapy

any additional VADs placed to complete therapy or supplement therapy

Time frame: An average of 14 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible ParticipantsNumber of Participants Requiring Additional VADs to Complete Therapy0 Participants
Midline Catheter, Randomized (PICC R)Number of Participants Requiring Additional VADs to Complete Therapy3 Participants
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Number of Participants Requiring Additional VADs to Complete Therapy1 Participants
Midline Catheter, Non-randomized (MC NR)Number of Participants Requiring Additional VADs to Complete Therapy4 Participants
Secondary

Number of Participants That Received Sedation for VAD Placement

sedation completed (yes/no)

Time frame: 1 day (day of enrollment/VAD placement)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible ParticipantsNumber of Participants That Received Sedation for VAD Placement4 Participants
Midline Catheter, Randomized (PICC R)Number of Participants That Received Sedation for VAD Placement3 Participants
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Number of Participants That Received Sedation for VAD Placement5 Participants
Midline Catheter, Non-randomized (MC NR)Number of Participants That Received Sedation for VAD Placement18 Participants
Secondary

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

Time frame: An average of 14 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible ParticipantsNumber of Participants Who Completed Therapy With Initial VAD4 Participants
Midline Catheter, Randomized (PICC R)Number of Participants Who Completed Therapy With Initial VAD1 Participants
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Number of Participants Who Completed Therapy With Initial VAD6 Participants
Midline Catheter, Non-randomized (MC NR)Number of Participants Who Completed Therapy With Initial VAD15 Participants
Secondary

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

Time frame: An average of 14 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible ParticipantsNumber of Participants With at Least One Complications2 Participants
Midline Catheter, Randomized (PICC R)Number of Participants With at Least One Complications3 Participants
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Number of Participants With at Least One Complications3 Participants
Midline Catheter, Non-randomized (MC NR)Number of Participants With at Least One Complications8 Participants
Secondary

Number of Participants With VAD Successfully Used for Blood Draws

at least one successful blood draw (yes/no)

Time frame: An average of 14 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible ParticipantsNumber of Participants With VAD Successfully Used for Blood Draws4 Participants
Midline Catheter, Randomized (PICC R)Number of Participants With VAD Successfully Used for Blood Draws2 Participants
Peripherally Inserted Central Catheter, Non-randomized (PICC NR)Number of Participants With VAD Successfully Used for Blood Draws5 Participants
Midline Catheter, Non-randomized (MC NR)Number of Participants With VAD Successfully Used for Blood Draws10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026