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Original article

Neonatal percutaneous central venous lines: fit to


burst
C Smirk,1 T Soosay Raj,1 A-L Smith,2 S Morris3
1
Neonatal Unit, Flinders Medical ABSTRACT
Centre, Bedford Park, Australia; Objective: To examine pressure changes in neonatal
2
Flinders Biomedical
Engineering, School of Medicine,
percutaneous central venous catheters under varying What is already known on this topic
Flinders University of South laboratory conditions and to quantify the risks of rupture in
Australia, Flinders Medical clinical practice. c Case reports have documented the potential for
Centre, Bedford Park, Australia; Design: We tested 27-gauge polyurethane Premicath and
3
Centre for Perinatal Medicine, rupture of neonatal percutaneous central venous
Flinders Medical Centre, Bedford
24-gauge silicone ECC (both Vygon, Norristown, PA) catheters and embolism of fragments.
Park, Australia catheters. Burst pressures were determined by applying a c Burst pressures and the risks of catheter rupture
slowly ramped pressure to catheters that were occluded with clinical use have not been clearly defined.
Correspondence to: at the tip. Flow–pressure relationships were defined by
Dr Scott Morris, Centre for
Perinatal Medicine, Flinders
increasing flow rates through patent catheters from 5 to
Medical Centre, Bedford Park, 499 ml/h. Pressure changes during the manual flushing of
South Australia 5042, Australia; catheters were determined for patent and occluded What this study adds
scott.morris@health.sa.gov.au catheters and with different syringe sizes.
Results: The mean burst pressure for polyurethane c Polyurethane Premicath central venous
Accepted 21 December 2008
Published Online First
catheters (1730.8 kPa, 95% CI 1634.7 to 1826.8) was catheters (CVCs) have a greater safety margin
3 February 2009 higher than for silicone catheters (275.6 kPa, 95% CI between recommended operating pressures and
240.4 to 310.8). Polyurethane catheters demonstrated an burst pressures when compared to silicone ECC
approximately fivefold greater margin of safety above CVCs.
manufacturer recommended operating pressures before c Patent polyurethane CVCs and silicone CVCs are
burst compared to silicone catheters. Pressures remained unlikely to rupture with standard pump
at safe levels in both catheters over the range of flows pressures or when flushed to administer
generally used in neonatal practice. Hand-flushing of medications.
obstructed silicone catheters caused rupture in 5/6 c Blocked silicone ECC CVCs rupture easily if
silicone catheters tested, in comparison to 0/16 flushing is attempted, and using a larger syringe
polyurethane catheters. size does not prevent rupture.
Conclusions: Polyurethane central venous catheters have
a greater pressure tolerance than silicone catheters and are
less likely to rupture under experimental conditions. METHODS
Obstructed silicone catheters rupture easily when flushed. Polyurethane 27-gauge CVCs (Premicath, Vygon,
Catheters were not tested in human infants. Norristown, PA) with the introducing wire removed,
and 24-gauge silicone CVCs (ECC, Vygon) were
tested. Used CVCs were collected after removal from
Neonatal percutaneous central venous catheters babies when no longer required for total parenteral
(CVCs) are frequently used for parenteral nutri- nutrition or drug administration, wiped and flushed
tion. In circumstances where venous access is with saline, and stored at 4uC until testing. For burst
difficult, CVCs are also used to give fluid boluses, pressure and infusion studies, a HPLC pump (P-500,
antibiotics or premedications for intubation. The Pharmacia Chemicals, Uppsala, Sweden) was used
rupture of CVCs and the embolisation of frag- to generate controlled high flow and pressure
ments have been described.1 2 However, the risk beyond the range of performance of pumps used in
of catheter rupture when flushing or administer- clinical practice. CVC pressures were recorded
ing rapid infusions via a CVC is unclear. There continuously during burst and infusion studies using
are no published data that adequately examine a digital oscilloscope (Virtual Instrument ADC-216,
the burst pressures of neonatal CVCs. Although PICO Technology, St Neots, UK) and a digital
Primhak et al described a burst pressure of manometer (DPM-II Universal Biometer, BioTek
between 520 and 700 kPa in four silicone 24- Instruments, Winooski, VT) for pressures
gauge CVCs in a letter to the editor, the authors ,689.5 kPa. Pressure measurements during manual
give no methodology and the validity of these flushing studies used the same digital manometer.
data is uncertain.3 We therefore conducted Studies were conducted over a 6-month period
experiments using new and used 27-gauge poly- from November 2007 to April 2008. The number of
urethane and 24-gauge silicone CVCs to ascertain new CVCs tested was determined by the con-
burst pressures in obstructed catheters, to explore straints of our budget and the number of used
the pressure tolerance of patent CVCs with CVCs tested reflected availability within the
variable flow rates, and to determine pressure chosen time frame. Silicone CVCs are used less
changes during the manual flushing of patent and commonly in our neonatal unit and therefore
obstructed CVCs. fewer used CVCs were available for testing.

F298 Arch Dis Child Fetal Neonatal Ed 2009;94:F298–F300. doi:10.1136/adc.2008.147900


Original article

Burst pressures of occluded CVCs 95% CI 1521.4 to 1838.7; p = 0.51). New silicone CVCs had a
Twenty three polyurethane (12 new and 11 used) and 14 silicone higher burst pressure (296.3 kPa, 95% CI 267.2 to 325.4) than used
(11 new and three used) CVCs were tested. Catheters were silicone CVCs (199.7 kPa, 95% CI 45.5 to 353.9) (p = 0.008).
obstructed at the tip with a short length of wire glued with The nature of rupture was different for the two CVCs.
cyanacrylate for polyurethane CVCs and by a mechanical clamp Polyurethane CVCs showed coiling with increasing pressure
for silicone CVCs. CVCs were placed unrestrained in a normal followed by a localised longitudinal 1–3 mm split that occurred
saline bath at 37uC. Water coloured with methylene blue was in various places along the catheter length. Silicone CVCs
infused via the pump at a set rate of 3 ml/h to achieve a slowly developed a localised bleb either at the hub or within 2.5 cm of
ramped pressure increase. Rupture was indicated by methylene the obstructed tip before longitudinal splitting at this site of focal
blue efflux into the bath. Burst pressure was recorded, and the thinning. No catheters split transversely or fragmented at bursting.
sites and type of rupture were documented using a microscope.
Pressures during constant flow in patent CVCs
Pressures during constant flow in patent CVCs Figure 2 shows the flow–pressure relationships for the two
Twenty two polyurethane (11 new and 11 used) and 14 silicone catheter types. Intraluminal pressure was linearly related to
(11 new and three used) CVCs were tested without obstruction flow for both CVCs (p,0.001) with a statistically greater
with the same temperature and infusate as used above. increase in pressure per unit increase in flow for the
Incremental flow rates from 5 to 499 ml/h were applied and polyurethane CVCs compared to the silicone CVCs (1.64
pressures recorded after several seconds at each flow rate once (95% CI 1.57 to 1.71) vs 0.37 (95% CI 0.29 to 0.44); p,0.001).
stabilised. Each catheter was tested once. There was no statistically detectable effect of new versus used
CVCs when this variable was included in the model.
Pressure changes during manual flushing For polyurethane CVCs, the package insert recommended
Sixteen new polyurethane and six new silicone CVCs were tested safe pressure (150 kPa) was exceeded at 100 ml/h but remained
with a different operator (neonatal intensive care nurse or doctor) below our measured burst pressures at 499 ml/h. For silicone
flushing each CVC. A standard central line infusion set-up was CVCs, pressure exceeded the recommended safe pressure limit
assembled on a bench top. A manometer was connected at the (100 kPa) at 300 ml/h and reached our range of measured burst
proximal end of the CVC. The catheter and manometer were pressures at 400 ml/h.
hidden behind a drape to blind the operator to pressure readings
and the cause of obstruction. Two clinical scenarios were provided Manual flushing
to each operator. In the first ‘‘bolus’’ scenario, the operator was The peak pressures generated by flushing obstructed polyur-
asked to flush the CVC with normal saline to clear the line of ethane CVCs (348.9 kPa, 95% CI 295.1 to 403.3) were greater
medication using 1, 2 and 10 ml syringes. They were instructed to than for patent polyurethane CVCs (169.6 kPa, 95% CI 142.7 to
flush as they would in normal practice and to flush proximal to the 196.5) (p,0.001). Higher pressures were generated flushing the
in-line bacterial filter. In the second ‘‘obstruction’’ scenario, the obstructed polyurethane CVCs with a 1 ml syringe in comparison
same CVC was obstructed at its tip and the operator was asked to to a 10 ml syringe, with similar pressures otherwise noted
clear the line flushing distally to the filter with the same choice of between syringe sizes (1 ml syringe 451.6 kPa, 95% CI 365.4 to
syringes. Peak pressures were recorded for each flush episode. The 537.8; 2 ml syringe 333.7 kPa, 95% CI 242.0 to 425.4; 10 ml
limit of measurement of the digital manometer was 689.5 kPa; syringe 239.2 kPa, 95% CI 157.2 to 321.3; p = 0.001 1 ml vs 10 ml
readings above this limit were recorded as 689.5 kPa for analysis. using one-way ANOVA). In all cases pressures were below our
observed range of burst pressures and no polyurethane CVCs
Statistical methods ruptured. No statistical differences in pressures generated were
Flow–pressure relationships were analysed using a linear noted for different syringe sizes when flushing patent lines.
regression model with random slopes in order to account for For silicone CVCs, peak pressures generated were higher in
the correlated structure of the data across flow rate. the obstructed group (245.5 kPa, 95% CI 146.9 to 343.4) as
Comparison of normally distributed data used an independent compared to the patent group (36.5 kPa, 95% CI 18.6 to 55.2)
samples t test or one way ANOVA with the Tukey post hoc (p = 0.002) and similar to the pressures measured in obstructed
multiple comparison test as appropriate. Categorical data were polyurethane CVCs (p = 0.057). No differences in pressures
analysed using the x2 statistic. Statistical calculations used SPPS were noted between syringe sizes for flushing silicone CVCs for
15.0 for Windows 2006 (SPSS) and Stata v 10 (StataCorp). either patent or obstructed catheters. Rupture of obstructed
silicone CVCs was frequent during flushing (5/6 silicone CVCs
RESULTS ruptured compared to 0/16 polyurethane CVCs; p,0.001).
Rupture occurred with both 1 ml and 10 ml syringe sizes. No
Burst pressures of occluded CVCs
ruptures occurred when flushing patent silicone catheters.
Time to rupture was 400–500 s for all CVCs. Figure 1 shows the
burst pressures for occluded catheters. The mean burst pressure
for polyurethane CVCs (1730.8 kPa, 95% CI 1634.7 to 1826.8) DISCUSSION
was higher than for the silicone CVCs (275.6 kPa, 95% CI 240.4 These data document the pressures generated under different
to 310.8) (p,0.001). The mean and lowest burst pressures for circumstances in two commonly used CVCs and help to quantify
the polyurethane CVCs were 11.5 and 8.7 times, respectively, the risks of rupture. Product information gives a similar safe
above the safety limit of 150 kPa noted in the packaging insert. pressure limit for both CVCs (150 kPa for the 27-gauge
The mean and lowest burst pressures for the silicone CVCs polyurethane Premicath, and 100 kPa working pressure or
were 2.6 and 1.6 times, respectively, above the working safety 120 kPa bolus pressure for the 24-gauge silicone ECC).
limit of 100 kPa also noted in the packaging insert. However, our data show an approximately fivefold greater safety
New and used polyurethane CVCs had similar mean burst margin before burst for the polyurethane CVC in comparison to
pressures (1777.3 kPa, 95% CI 1645.4 to 1909.1 vs 1680.1 kPa, the silicone CVC. Silicone CVCs showed a narrow safety margin

Arch Dis Child Fetal Neonatal Ed 2009;94:F298–F300. doi:10.1136/adc.2008.147900 F299


Original article

Figure 2 Flow–pressure relationships for patent polyurethane


Figure 1 Burst pressures for occluded polyurethane Premicath and Premicath and silicone ECC central venous catheters (CVCs). Comparison
silicone ECC central venous catheters (CVCs). Burst pressures for is made to observed burst pressure in occluded CVCs.
individual CVCs are shown, with box plots summarising the data. New
CVCs are indicated by open symbols, and used CVCs by symbols with
cross hairs. Solid lines indicate manufacturer safety limits for Premicath particular conditions of this laboratory study cannot be directly
(upper line) and ECC (lower line). extrapolated to clinical practice. CVCs were not tested in human
infants. Burst pressures for silicone CVCs in this study are
to burst above the manufacturer’s recommended pressures. The considerably less than those recorded in four CVCs by Primhak et
comparative resilience of the polyurethane CVC was not affected al, although these authors’ methodology is unclear.3 The finding
by routine clinical use. In contrast, measured burst pressures of that 24-gauge silicone CVCs may become more susceptible to
used silicone CVCs tended to be lower than those of new CVCs. burst after normal clinical use requires further study, and no firm
Higher pressures were generated in the polyurethane CVCs conclusion can be drawn from the data due to small numbers.
with constant flow when compared to silicone CVCs. This The greater pressure tolerance of the 27-gauge polyurethane
reflects the less distensible polyurethane catheter wall and CVC has implications for neonatal practice. In our neonatal
smaller catheter diameter. The data indicate that flow rates unit this CVC is used more frequently than silicone CVCs in
used in neonatal practice would be unlikely to cause rupture. babies of all sizes because of ease of insertion and a capacity to
Factory default pressure settings on standard neonatal infusion tolerate high infusion rates with acceptable pressure. The
pumps are less than 100 kPa and with these limits high flows exception is where central placement of the tip is essential
are achievable in both CVC types. and the polyurethane CVC is too short to allow this. Any CVC
Hand flushing of medication in patent CVCs appears safe. where pump pressure is exceeded is considered blocked and
However, despite the use of experienced neonatal nurses and electively replaced rather than hand-flushed. It should however
doctors, blocked silicone CVCs usually ruptured with hand be emphasised that a lower risk of rupture does not indicate
flushing. This practice should therefore be abandoned. The use of that the polyurethane CVCs are safer than silicone CVCs in
larger syringe sizes to minimise risk of rupture of blocked silicone other respects. This is highlighted by data suggesting a greater
CVCs, as suggested by Primhak et al and product information, is incidence of pericardial and pleural effusion with polyurethane
not supported by our data.3 Flushing a blocked Premicath also CVCs in comparison to silicone CVCs.5
generated widely variable and high pressures, and although no
Acknowledgements: The authors acknowledge Jeanette Birtles for assistance with
catheters ruptured and pressures generated were well below our equipment, and Richard Woodman for statistical advice. We purchased 10 ECC and 10
range of measured burst pressures, given the limited number of Premicath CVCs at cost price from Vygon Australia for this study.
CVCs tested this practice is also not recommended. Funding: Purchase of central venous catheters was funded within the Flinders
Salis et al described burst pressure tolerance of larger calibre 16- Medical Centre Neonatal Unit equipment budget.
and 18-gauge CVCs under conditions of power injection for Competing interests: None.
radiographic studies.4 Although their experimental conditions and
Ethics approval: Ethics approval was obtained from the Flinders Medical Centre
pressure data are not immediately relevant to neonatal practice, Human Research Ethics Committee.
lower burst pressure was documented for silicone CVCs in
comparison to polyurethane CVCs. These and our current data
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F300 Arch Dis Child Fetal Neonatal Ed 2009;94:F298–F300. doi:10.1136/adc.2008.147900

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