How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics

Ethics

The Children’s Health Service District, Queensland (Human Research Ethics Committee/15/QRCH/164), and Griffith University (2016/077) Human Research Ethics Committees provided ethics and governance approval. Informed consent was obtained from parents or legal guardians, with children providing youth assent if they were 7 years or older, dependent upon cognitive ability.

RESULTS

Participant and PICC Characteristics

Participant and PICC characteristics are described in Table 1. The majority of participant and PICC characteristics were balanced between intervention groups. The mean patient age was 7.3 years (standard deviation 5.0; range 0-18). PICC insertion was most commonly for a respiratory diagnosis (n = 98; 65%). Most PICCs were placed in the basilica vein (n = 115; 79%), with insertion being successful on the first attempt (n = 125; 86%). There was some imbalance (>10% absolute difference between groups) in nurse practitioner and registrar insertions (standard care 35% and 23% vs BioFlo^® 51% and 8%, respectively) and patients with leucocytes <1000 µl (standard care 10% vs BioFlo^® 22%). Optimal PICC tip location at the cavoatrial junction was higher with BioFlo^® than standard care, although this difference was <10%.

Feasibility Outcomes

As shown in Figure 1, the majority of feasibility criteria were met, with 94% of 188 screened patients being eligible to participate and 97% of eligible patients consenting to enroll. Of 150 patients randomly assigned, 4 (1 in standard care and 3 in BioFlo^®) were unable to have a PICC inserted or the procedure was cancelled. Demographic data only were collected for these 4 patients. No participants were lost to follow-up, and no primary outcome data were missing. Staff satisfaction with insertion kit and ease of insertion, ease of removal of the PICC, and parental confidence in the PICC product were similar across both groups (Table 2).

PICC Failure and Complications

In total, 24 of 146 participants (16%) experienced PICC failure. There were 16 (22%) failures of standard care PICCs and 8 (11%) failures of BioFlo^® PICCs. This corresponded to incident rates of 12.6 and 7.3 per 1000 catheter days (incident rate ratio 0.58; 95% CI, 0.21-1.43; P = .172; Table 2). Failure was most commonly from thrombosis (n = 5; 7%) or occlusion (n = 5; 7%) in the standard care group, with lower incidences in the BioFlo^® group (n = 2 [3%] and n = 1 [1%], respectively). Figure 2 displays survival from PICC failure.

Considering the entire PICC dwell, of the 74 standard care patients, 49 (66%) had no complications, 9 (12%) had complications during the dwell but none at removal, 2 (3%) had no complications during the dwell but had a complication (ie, failure) at removal, and 14 (19%) had complications during the dwell and at removal. For the 72 BioFlo^® patients, 61 (85%) had no PICC complications, 3 (4%) had complications during the dwell but none at removal, 4 (5.5%) had no complications during the dwell but had a complication (ie, failure) at removal, and 4 (5.5%) had complications during the dwell and at removal.

More than twice as many standard care patients as BioFlo^® patients had a complication during the PICC dwell, and this difference was statistically significant (25 of 74, 34% vs 11 of 72, 15%; P = .009; Table 2). These results are consistent with the Kaplan-Meier curve, which shows longer complication-free survival with BioFlo^® (Figure 2A and 2B). The median BioFlo^® dwell was 1 day longer (13.8 vs 12.9 days), and the median time to first complication was one day later (4.0 BioFlo^® vs 3.0 standard care; Table 2).

As per supplementary Table 1, univariate Cox regression identified PICC failure as significantly associated with tip placement in the proximal superior vena cava (SVC) compared to the SVC–right atrium junction (HR 2.61; 95% CI, 1.17-5.82; P = .024). Reduced risk of PICC failure was significantly associated with any infusion during the dwell (continuous fluid infusion, P = .007; continuous antibiotic, P = .042; or intermittent infusion, P = .046) compared to no infusion. Other variables potentially influencing the risk of failure included PICC insertion by nurse specialist compared to consultant anesthetist (HR 2.61; 95% CI, 0.85-5.44) or registrar (HR 1.97; 95% CI, 0.57-6.77). These differences were not statistically significant; however, baseline imbalance between study groups for this variable and the feasibility design preclude absolute conclusions.

DISCUSSION

This is the first pilot feasibility trial of new PICC materials and valve design incorporated in the BioFlo^® PICC in the pediatric population. The trial incorporated best practice for randomized trials, including using a concurrent control group, centralized and concealed randomization, predetermined feasibility criteria, and a registered and published trial protocol.¹⁷ As in other studies,^15,24,34 PICC failure and complication prevalence was unacceptably high for this essential device. Standard care PICCs failed twice as often as the new BioFlo^® PICCs (22% vs 11%), which is a clinically important difference. As researchers in a pilot study, we did not expect to detect statistically significant differences; however, we found that overall complications during the dwell occurred significantly more with the standard care than BioFlo^® PICCs (P = .009).