Volume 2 Issue 2

Introduction

Neonates admitted to a neonatal intensive care unit (NICU) rely highly on vascular access for administering fluids, nutrition, blood and blood products and medication. In particular, preterm or critically ill infants are slow to tolerate the introduction of enteral feeding because of immaturity of the gastrointestinal tract, delayed gastric emptying and intestinal peristalsis¹. Peripheral intravenous cannula (PIVC) is the most common method to administer medication in premature infants in the NICU². Although PIVC placement is one of the most routine procedures in pediatric and neonatal care, there are limited published data on this procedure in NICUs³. PIVC therapy is not without risk. Complications such as clotting, occlusion, leakage, infiltration, extravasation, phlebitis and infection occur^{2, 4}. The incidence of these complications has remained relatively constant over the last 30 years² with no studies reporting on complication rates in neonates during the last decade. Infiltration, leaking, and occlusion account for the removal of 95% of all PIVCs⁵. Infiltration is the unintended administration of non-vesicant intravenous (IV) fluid outside the vein⁶. Infiltration can cause permanent skin damage of the hand, foot and scalp and cause nerve or tendon damage, which may lead to loss of movement over joints⁷. These complications increase morbidity and prolong hospital stay, which may lead to higher treatment costs.

Placement of a PIVC is painful and the American Academy of Pediatrics stresses that the number of painful disruptions in neonatal care should be minimized⁸.

In a recent study from The Netherlands⁹, the mean number of painful procedures per neonate per day was 11.4 (SD 5.7). In an earlier Canadian study this number was even as high as 16¹⁰.

To limit the number of painful procedures it would be important to reduce the number of attempts needed to insert a PIVC. Successfully inserting a PIVC on the first attempt in premature infants is difficult and often the neonate is subjected to unsuccessful attempts.

Furthermore, premature infants are vulnerable to infections due to their compromised immune system¹¹. A high complication rate and thus decreased indwelling time as well as repeated attempts for PIVC (re-)placement consequently will damage the skin barrier and further predispose the infants to infections¹².

One intervention that may help reduce the number of attempts and the incidence of post-insertion complications is setting up a group of dedicated healthcare professionals, which the literature refers to as a vascular access specialist team^{13, 14}. With this approach the vascular access specialist team have clinical responsibility for vein assessment, PIVC insertion and maintenance, along with staff education and trouble-shooting of catheter problems^{11, 15}. In prospective studies, activities of such teams proved effective in reducing IV complications11,^15-19.

In two NICUs in The Netherlands, a recent expansion of the role of the IV nurse in vascular access specialist teams was initiated at the Wilhelmina Children’s Hospital (WKZ) and the Sophia Children’s Hospital (SKZ). The IV nurses were implemented to improve PIVC management and thus reduce PIVC complications and the number of attempts at PIVC placement before successful insertion.

The aim of this study is (i) to quantify the incidence and type of complications in these two hospitals and (ii) to identify factors associated with these complications such as PIVC insertion by a discipline of the PIVC inserter: neonatologist, physician assistant, IV nurse, or resident. We hypothesized that a good understanding of PIVC complications in neonates will increase the quality and safety of IV management.

Method

Patients and settings

A prospective observational design was used to examine two cohorts of neonates with PIVCs in level III NICUs of two university medical centers (UMC) in The Netherlands. Both study units are primarily designated for critically ill neonates.

We included all consecutive neonates in need of a PIVC and admitted to the NICUs between September 1^st 2013 and March 31^st 2014.

We excluded neonates with major congenital malformations of the veins and neonates requiring total body cooling for the management of hypoxic ischemic encephalopathy that obstructed intravenous access.

We calculated that a sample of at least 200 PIVCs was clinically pragmatic and sufficient to provide a heterogeneous sample that contains all important factors that contribute to complications and is large enough to deal with potential -biases²⁰.

Data collection

PIVC data were collected on a case report form validated in SKZ, Rotterdam, The Netherlands. The following data were noted: insertion and removal dates and times, eight items concerning patient characteristics, reason for PIVC placement, discipline of the inserter, vein assessment, number of insertion attempts, location of the PIVC, PIVC device size and reason for PIVC removal. Elective PIVC removal is defined as removal in the absence of an indication for IV therapy or IV medication.

The inserter or remover of the PIVC entered the data on the case report form immediately after insertion and upon removal of the PIVC.

Ethics

This study was approved by the Women and Baby division of the UMC Utrecht in The Netherlands. The study protocol (protocol number 14-031/C) was approved by the local Medical Ethics Committee. The study consisted of observations only and data were stored and analyzed in such a manner that individual patients cannot be identified directly.

Outcome measures

Outcomes of interest included (i) patient characteristics; (ii) skin color; (iii) diagnosis; (iv) characteristics of devices used; (v) type of the complications; (vi) number of insertion attempts in relation to the discipline of the inserter; (vii) indwelling time; (viii) factors related to complications.

Statistical analysis

Descriptive analyses were performed. The categorical variables skin color, diagnosis, PIVC brand, PIVC location, vein visualization device, discipline of the inserter and birth-weight group were compared between the two settings using Chi-square test or Fisher’s exact tests.

Binary logistic regression analysis was used to determine a contribution to the occurrence of complications. The forced entry method was used to test all predictor variables in one block. The following variables were entered in the model: birth-weight group (i.e. <1000 g, >1000 g, ≤1500 g, >1500 g, discipline of the inserter, vein visualization device and location of the PIVC. In addition, binary logistic regression analysis was used to determine factors associated with insertion success. In this approach the predictive ability is assessed while controlling for the effect of the other variables in the model. The assumption that there are no high inter-correlations between predictor variables was assessed by collinearity statistics. Cox & Snell R squared and Nagelkerke R squared were used to test the usefulness of the model.

All statistics were performed using SPSS (version 20.0; SPSS Inc., Chicago, IL, USA) and p<0.05 was considered statistically significant.

Results

Between September 1^st 2013 and March 31^st 2014, a total of 518 catheters were inserted in 235 infants (Tab. I). The mean birth-weight was 1709 g with a minimum of 365 g and maximum of 4540 g. The mean gestational age (GA) was 31 weeks and 4 days with a minimum of 23 weeks and 6 days and a maximum of 42 weeks and 2 days. The most common diagnosis for admission was prematurity (68%). In 69% of the study population the skin color was white. No insertion aids were used in 38% of all insertion attempts. The first-time success rate was 45% (N = 234).

TABLE I - Patient characteristics (n = 235)



SKZ = Sophia Children’s Hospital; WKZ = Wilhelmina Children’s Hospital.
 

 

Complication rate and catheter characteristics

 

Procedural and catheter information of successful insertions are presented in Table II. Removal of the catheter because of any type of complication occurred in 56% (N = 288) of patients. The predominant reason for non-elective removal due to complication was infiltration (N = 193 [67%]) followed by leakage of the connection of the PIVC hub to the IV administration set (N = 53 [18%]) (Tab. III).

TABLE II - Procedural and catheter information



CL = central line; IV = intravenous; SD = standard deviation.


TABLE III - Reasons for catheter removal (n = 518)



In the WKZ, 20% of removals were elective on the grounds of end of IV therapy versus 7% in the SKZ.

 

The reason for removal was missing in 150 PIVCs (29%). The mean indwelling time was 47 hours ± 43 (SD); it was -longest when inserted by a member of the vascular access specialist team (Tab. IV).

TABLE IV - Number of insertion attempts and indwelling time per discipline

IV = intravenous; SD = standard deviation.

 

Factors associated with PIVC complications in this sample

 

There was a significant association between birth-weight group >1500 g and whether or not a catheter needed to be removed due to a complication. Chi-square 13.40, p<0.001 (df2). No significant association was found between catheter removal due to a complication and discipline of the inserter, vein visualization device and location of the PIVC. No association was found between the studied variables and number of insertions.

 

Attempts needed for successful insertion of the PIVC

 

One to 10 attempts (median 2) were needed for successful insertion. There was a significant association between the discipline of the inserter and whether or not the PIVC was successfully inserted; Chi square (df4) 33.8; p<0.001. The odds of a PIVC being inserted with success was 2.3 times higher if inserted by a neonatologist than by a resident; 2.11 for physician assistant versus resident; 1.7 for neonatologist versus IV nurse; 1.6 for physician assistant versus IV nurse; and 1.1 for neonatologist versus physician assistant (Tab. IV).

 

Discussion

 

In this study 56% of the PIVCs were removed on the grounds of a complication, predominantly infiltration (67%). The factor that was associated with complications is birth-weight. Furthermore, neonatologists had the highest success rate for PIVC insertion.

 

The complication rate of 56% in the study population is higher than that of a previous prospective study (50%)²¹. This may be explained by a shift from premature to extremely premature in the neonatal populations of the two Dutch centers. A review on techniques for maintaining catheter security found a complication rate ranging from 0% to 78% in the various studies². The complication rate in our study may be biased by the high percentage of missing reasons for catheter removal: 29% (Tab. III). Infiltration accounted for two-thirds of all complications. Additionally, in one study infiltration was the major complication of PIVC therapy with reported incidences from 23% to 78%².

 

Regarding factors associated with PIVC complications, the strongest predictor for PIVC removal on the grounds of a complication was birth-weight >1500 g. Significantly more PIVCs were inserted by residents in the birth-weight group >1500 g. Residents are still in training and have less experience in inserting PIVCs than neonatologists with many years’ working experience. Residents are recommended to practice inserting a PIVC in larger neonates, which is assumed to be easier.

 

A subsequent study with a larger sample is warranted to explore a more precise effect of the other factors associated with PIVC complications.

 

The number of neonates with white skin color was larger at the WKZ than the SKZ. Inserting in a lighter skin is considered easier. However, in the SKZ fewer inserting aids were used; 43% of PIVC inserters at the SKZ did not use an inserting aid versus 32% in the WKZ. Despite the differences in skin color between institutions no difference in number of attempts needed for successful insertion was found.

 

Professional discipline was not significantly associated with complications. This confirms the findings of a recent study which describes that a well-trained and dedicated vascular access specialist team employing a high procedural volume can have beneficial patient- and device-related outcomes that are not necessarily linked to the clinicians’ professional background²².

 

A total of 1151 attempts resulted in 518 inserted PIVCs in 235 infants. The median attempt rate of 2.0 (range 1-10) compares well with the study reported by Franck et al⁵, i.e. median 2.2^1-12. Possibly a vascular access specialist team could increase the success rate over time since members will become more skilled after repeated insertions and education¹⁴. Neonates are more sensitive to pain than older children and this hypersensitivity is exacerbated in preterm neonates^{10, 23}. Unfortunately, these critically ill infants endure failed attempts.

 

The results suggest that the number of attempts needed for successful insertion is linked to the professional background. We did not record the experience or procedure volume per inserter and therefore we cannot draw conclusions with regard to experience of the inserter. However, the neonatologists and the physician assistants in our study had the highest success rate but have amassed more clinical exposure to PIVC insertion in the neonatal population. The residents needed the most attempts. This could suggest that consistently and repeatedly performing PIVC insertions makes neonatologists and physician assistants more skilled than residents, who perform these interventions less often¹⁹. However, to have ‘experience’ is not enough. Appropriate training is also required for peripheral vein cannulation in neonates. This training should include knowledge of appropriate materials and the most appropriate methodology. Healthcare professionals who insert PIVCs as in our study (i.e. neonatologist, physician assistants, residents and IV nurses) should be appropriately trained in specific neonatal PIVC procedures during their academic and employment training period. Additionally, revalidation should occur to ensure this clinical skill is contemporaneous and reflective of empirical guidelines and policy.

 

All complications detected in this study could be a way to measure outcomes of a standardized appropriate training. A dedicated vascular access specialist team is mandatory in cases of predicted difficult peripheral vein access in which ultrasound or near-infrared technology may be useful.

 

It is expected that when the vascular access specialist team nurses, who are trained and have appropriate knowledge of the materials, develop expertise in PIVC insertion, this will lead to an increase in successful insertions over time. However, PIVCs placed by an IV nurse had the longest indwelling time. We did not record the experience or procedure volume per inserter and therefore we cannot draw conclusions with regard to experience of the inserter.

 

Strengths and limitations

 

A strength of this study is a focus on all potential factors that may contribute to complications in PIVC management. To our knowledge this is the first study reporting on insertion attempts per clinicians’ professional background in an NICU setting.

 

Although we analyzed a cohort of 518 PIVCs, a limitation should be considered. A large number of reasons for PIVC removal were missing, probably due to hectic proceedings at the ward, and lack of time to complete the case record form.

 

Repeated and prolonged pain exposure alters a neonate’s pain process, long-term development, and behavior^{10, 23, 24}. Clinicians therefore should aim to limit the number of attempts needed for successful insertions and decrease infection rates and complications.

 

Conclusion

 

This study reveals that the majority of PIVCs were removed after the occurrence of a complication with the most frequent of these being infiltration. Based on the results of the present study, neonatologists and physician assistants should be the preferred PIVC inserters. Additionally, we expect that the nurses who recently joined the installed vascular access specialist team will become more skilled in inserting PIVCs as they increase their procedural hours and first-time insertion successes. As a result, they will likely develop expertise in neonatal PIVC insertion resulting in improved and sustained success rate. We belief this model of care will allow vascular access specialist teams to provide PIVC insertion and maintenance in the neonate population. Furthermore, this could decrease the workload of the neonatologists and physician assistants with regard to PIVC insertion, and allow them attend to other clinical duties.

 

Recommendations

 

An ongoing effort is still needed to reduce complication rates and insertion attempts in the NICU population. Targeted strategies to identify and prevent infiltration in a NICU population are required. The use of a vascular access specialist team is clinically reasonable and justifiable, however, future interventional studies should attempt to improve first time insertion success and reduce PIVC failure from infiltration in the neonate population. These clinical outcomes should take into account the influence of clinician factors, patient factors, along with materials and products used.

 

Moreover, a case record form integrated in the electronic patient file is recommended as a feasible instrument to prevent missing data in future studies and to continuously monitor PIVC-related complications in clinical practice.

 

Acknowledgment

 

The authors thank Ko Hagoort for editing and Geja van Blijderveen, Eline de Kok, Annemiek Korver and Marjanne Zielman for advice on this paper.

 

Disclosures

 

Financial support: No grants or funding have been received for this study.

 

Conflict of interest: None of the authors has financial interest related to this study to disclose.

 

 

Published online: May 31, 2016

Author(s)

Monique Legemaat1,2, Peter J. Carr3,4, Roland M. van Rens5, Monique van Dijk6, Irina E. Poslawsky2,7, Agnes van den Hoogen2,8 1 Merem Asthma Centre Heideheuvel, Hilversum - The Netherlands 2 Nursing Science, Program in Clinical Health Sciences, Faculty of Medicine, Utrecht University, Utrecht - The Netherlands 3 Department of Emergency Medicine, The University of Western Australia, Perth - Australia 4 Alliance for Vascular Access Teaching & Research Group, Griffith University, NHMRC Centre of Research Excellence in Nursing Interventions in Hospitalised Patients, Menzies Health Institute Queensland, Griffith University, Nathan - Australia 5 Hamad Medical Corporation, Women’s Hospital Doha, Doha - Qatar 6 Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia’s Children’s Hospital, Rotterdam - The Netherlands 7 Division of Neuroscience, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht - The Netherlands 8 Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Center, Utrecht - The Netherlands Corresponding author: Agnes van den Hoogen, Clinical Health Science Research & Education, Division Woman and Baby University Medical Center Utrecht P.O. Box 85090 3508 AB Utrecht, The Netherlands Email ahoogen@umcutrecht.nl Pages 19-25

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