Evaluation of a diluted lipid emulsion solution as a lubricant for improved peripherally inserted central catheter guidewire removal in a neonatal population

The study design and procedures (MRC-01-20-890) were approved by the local Institution Review Board (IRB). As the data source was anonymized, the local IRB committee determined the study an ‘observational chart review’ and that participant consent was not required.

A retrospective, cross-sectional study, using routinely collected anonymized intravenous device data was performed from January 2019 through July 2020. The primary outcome of interest was the occurrence of therapy failure (e.g., leaking, breakage) in relation to PICC guidewire removal leading to any unplanned device removal prior to completion of therapy. The study was performed in the 112-bed NICU of the Women’s Wellness and Research Centre (WWRC) of Hamad Medical Corporation (HMC), Doha, Qatar.

Study participants, nor parents were not involved in the design, conduct or reporting of this study. Retrospective data were retrieved from the electronic data management system of the facility.

Infants who were admitted to the NICU and who needed intravenous therapy through a 1Fr./28G or 2Fr./24G PICC were included in this study. Participants were excluded from the sample if the data collection was incomplete or whenever the data was related to the use of other devices e.g., peripheral IV catheters, umbilical venous catheters (UVC) or PICCs exceeding 2Fr./24G.

During the patient assessment stage, the vascular access team follows a locally developed mnemonic, the “5Rs for Vascular Access” i.e., the Right device, for the Right vein, with the Right therapy, for the Right duration, for the Right patient, as described in a similar concept by Steere et al. [13] Venous cannulation is strictly performed under guidance of the local hospital policy, based on current evidence-based recommendations and guidelines [14, 15]. In this study setting, a PICC insertion is routinely performed by doctors and nurses from the neonatal vascular access team (neoVAT). The selection of appropriate veins are performed using near-Infra-Red (n-IR) technology for vein visualization (Christie Medical Holdings, Lake Mary, Florida, USA). In this facility’s practice, the choice for a central vascular access device is based upon the abovementioned 5Rs, with the required duration, fluid characteristics (pH and osmolarity) and patient characteristics (body weight and/or a known history of difficult vascular access). The 5Rs for Vascular Access-concept is represented in Fig. 1 and are based upon current standards of care [14, 15] and also considers product compatibility, hospital purchasing decisions and practitioner consensus.

All preflush solutions were prepared at the bedside, under sterile conditions. For the DLS, a 1 ml lipid 20% was diluted with 9 ml normal saline, the NSS was provided as prefilled 10 ml syringe flushes. Preflushes of NSS and DLS were provided alternated for the daily PICC insertions. Note: all PICCs were checked and flushed outside the patient and before the actual insertion procedure, to avoid excessive infusion of the preflush solution. Once the PICC was successfully inserted, the guidewire was then removed without any further flushing with either the NSS or DLS solutions. Total filling volumes of these PICC’s are extremely small and would vary between a maximum of 0.09-0.12 ml, depending on type and length of the device. During guidewire removal, a small amount of the DLS volume is removed due to adhesion of the fluid to the guidewire.

Patients demographics and baseline data included sex, gestational age at birth in weeks and days, birth weight, and current body weight in grams. Data regarding the procedure of intravenous cannulation were the date and time of cannulation, including the number of attempts to successful cannulation, cannulated extremity, used type and size of vascular access device, indication for intravenous treatment, type of preflush used, any noted resistance during guidewire removal, date and time of PICC removal, total PICC dwell time in days, and the reason for PICC removal.

A total of 507 cases were retrospectively collected between January 2019 through to July 2020. Descriptive statistics were used to summarize and determine the sample characteristics and distribution of study participants data. The normally distributed data and results were reported with mean and standard deviation (SD); the remaining results reported with median and inter-quartile range (IQR). Categorical data were summarized using frequencies and proportions. Associations between two or more qualitative data variables were assessed using Chi-square (χ2) test or Fisher Exact test as appropriate. Quantitative data between the two independent groups were analyzed using unpaired t or Mann Whitney U test as appropriate. Univariate and multivariate logistic regression analysis (controlling and adjusted for potential predictors and confounders such as type of preflush, gender, resistance of the guidewire, days at insertion, birthweight, gestation at birth, number of attempts, extremity of cannulation, catheter characteristics, indication for intravenous therapy, indwell time) were applied to determine and assess the associations and predictive values of predictors and confounders stated above with binary outcome variable risk for failure of intravenous access devices. For multivariate logistic regression models, predictor variables were considered if statistical P < 0.10 level in univariate analysis or if determined a priori to be clinically important. The results of logistic regression analyses were presented as odds ratio (OR) with corresponding 95% CI. Receiver operating characteristic curve (ROC) was computed and constructed to evaluate and assess predictive accuracy and discriminative ability of the developed logistic regression model (based on the predicted probabilities) using potential significant variables found in the multivariate logistic regression model. All P values presented were two-tailed, and P values < 0.05 was considered as statistically significant. All Statistical analyses were done using statistical packages SPSS version 27.0 (Armonk, NY: IBM Corp) and Epi-info (Centers for Disease Control and Prevention, Atlanta, GA) software.

To the authors knowledge, this is the first study of this kind to evaluate the effect of a lipid-enhanced catheter preflush solution to assist PICC guidewire removal in the neonatal population worldwide. All eligible neonates were included during the study period, with the larger sample size representative of the facility’s neonatal PICC use. This helped increase the power of the study’s findings, helping to minimize any selection bias and increase the generalizability of the findings to similar settings.

Despite its strengths, this research also has some limitations. This study was a single center, retrospectively collected dataset, and in contrast to controlled randomized studies, this method creates risk of selection bias. During this study, every infant with a successfully inserted PICC was included to minimize the risk of selection bias. Data outcomes were not available for neonates transferred out of the facility. Although this number was relatively small, patients lost to follow-up may have differing outcomes than those who were included in this analyzed population. Nonetheless, future randomized control trails should focus on the continuous introduction of novel and clinically beneficial strategies to improve infusion therapy outcomes.