Catheterization of central vessels can be associated with early and late, potentially fatal complications. A proactive approach is imperative to reduce the frequency and magnitude of adverse events. Recently, the GAVeCeLT has proposed a protocol called SICA-PED (i.e. Safe Insertion of Central Access in Pediatric patients) and includes seven evidence-based strategies.
Methods:
Through a single-center prospective observational study, the authors wanted to consolidate the efficacy and safety of these protocol in newborns. In a series of 104 newborns, the seven steps of the protocol were applied (1) pre-procedural ultrasound study of the RaCeVA veins, (2) correct aseptic technique, (3) ultrasound-guided venipuncture, (4) intraprocedural localization of the tip of the catheter with TTE (ECHO TIP) and (iECG) intracavitary electrocardiogram, (5) reasoned choice of the implant exit site with the RAVESTO Tunneling technique, (6) anchoring without stitches, and (7) exit point protection with the use of glue and transparent semipermeable membrane. The authors have included a further precaution in point (6) the subcutaneous anchoring system has added the counter-fixation of the catheter wings that we will call 6Plus Point.
Results:
All infants requiring implantation of elective us-guided central venous access were enrolled in the study. None of the 104 implanted central venous catheters experienced early complications (accidental arterial puncture, PNX, primary malposition); rare late complications such as ecchymosis, CRBSI, exit site infection or dislodgement were observed, No catheter-related thrombotic phenomena were observed. The CRBSI catheter-related infection rate was 2.47 × 1000 days catheter cases.
Conclusion:
The results of this prospective study strengthen the feasibility and efficacy of the SICA-Ped Protocol. Demonstrating that the systematic application of the evidence-based seven-step implantation strategy increases the success rate, minimizes early and late complications, which result in increased patient safety.
BaroneGPittirutiM.Epicutaneo-caval catheters in neonates. New insight and new suggestion from the recent literature. J Vasc Access2020; 21: 805–809.
2.
BaroneGD’AndreaVAncoraG, et al. The neonatal DAV-expert algorithm: a GAVeCeLT/GAVePed consensus for the choice of the most appropriate venous access in newborns. Eur J Pediatr2023; 182: 3385–3395.
3.
UllmanAJMarshNMihalaG, et al. Complications of central venous access devices: a systematic review. Pediatrics2015; 136(5): e1331–e1344.
4.
BresciaFPittirutiMOstroffM, et al. The SIC bundle: a seven-step strategy to minimize complications potentially related to the insertion of centrally inserted central catheters. J Vasc Access. Epub ahead of print 29 July 2021. DOI: 10.1177/11297298211036002.
5.
EmoliACappuccioSMarcheB, et al. Il protocollo ‘ISP’ (Inserzione Sicura dei PICC): un “bundle” di otto raccomandazioni per minimizzare le complicanze legate all’impianto dei cateteri centrali ad inserimento periferico (PICC) [The ISP (safe insertion of PICCs) protocol: a bundle of 8 recommendations to minimize the complications related to the peripherally inserted central venous catheters (PICC)]. Assist Inferm Ric2014; 33(2): 82–89.
6.
BresciaFPittirutiMOstroffM, et al. The SIF protocol: a seven-step strategy to minimize complications potentially related to the insertion of femorally inserted central catheters. J Vasc Access. Epub ahead of print 29 August 2021. DOI: 10.1177/11297298211041442.
7.
PronovostPNeedhamDBerenholtzS, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med2006; 355(26): 2725–2732.
8.
BellTO’GradyNP.Prevention of central line-associated bloodstream infections. Infect Dis Clin North Am2017; 31(3): 551–559.
9.
BiasucciGDismaNMPittirutiM.Vascular access in neonates and children. Book. Springer International Publishing, 2022 Switzerland AG.
10.
PittirutiMCelentanoDBaroneG, et al. A GAVeCeLT bundle for central venous catheterization in neonates and children: a prospective clinical study on 729 cases. J Vasc Access 2023 Nov; 24(6):1477-1488.
11.
LampertiMBiasucciDGDismaN, et al. European Society of Anaesthesiology guidelines on peri-operative use of ultrasound-guided for vascular access (PERSEUS vascular access). Eur J Anaesthesiol2020; 37(5): 344–376.
12.
SpencerTRPittirutiM.Rapid central vein assessment (RaCeVA): a systematic, standardized approach for ultra- sound assessment before central venous catheterization. J Vasc Access2019; 20(3): 239–249.
13.
O’GradyNPAlexanderMBurnsLA, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis2011; 52(9): e162–e193.
14.
Zito MarinosciGBiasucciDGBaroneG, et al. ECHOTIP-Ped: a structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in pediatric patients. J Vasc Access. Epub ahead of print 13 July 2021. DOI: 10.1177/11297298211031391.
15.
BaroneGPittirutiMBiasucciDG, et al. Neo-ECHOTIP: a structured protocol for ultrasound-based tip navigation and tip location during placement of central venous access devices in neonates. J Vasc Access. Epub ahead of print 5 April 2021. DOI: 10.1177/11297298211007703.
16.
RossettiFPittirutiMLampertiM, et al. The intracavitary ECG method for positioning the tip of central venous access devices in pediatric patients: results of an Italian multicenter study. J Vasc Access2015; 16(2): 137–143.
17.
MastroianniRCapassoAAusanioG.The intracavitary electrocardiography method for tip location of jugular internal vein access device in infants of less than 5 kg: a pilot study. J Vasc Access2018; 19(6): 639–643.
18.
MoureauNLMarshNZhangL, et al. Evaluation of skin colonization and placement of vascular access device exit sites (ESCAPE study). J Infect Prev2019; 20(1): 51–59.
19.
GilardiEPianoAChelliniP, et al. Reduction of bacterial colonization at the exit site of peripherally inserted central catheters: a comparison between chlorhexidine-releasing sponge dressings and cyano-acrylate. J Vasc Access2021; 22(4): 597–601.
20.
OstroffMDMoureauNPittirutiM.Rapid assessment of vascular exit site and tunneling options (RAVESTO): a new decision tool in the management of the complex vascular access patients. J Vasc Access2021. Epub ahead of print 21 July 2021. DOI: 10.1177/11297298211034306.
21.
GorskiLAHadawayLHagleME, et al. Infusion therapy standards of practice, 8th edition. J Infus Nurs2021; 44(1S Suppl 1): S1–S224.
22.
D’AndreaVPezzaLBaroneG, et al. Use of cyanoacrylate glue for the sutureless securement of epicutaneo-caval catheters in neonates. J Vasc Access2021. Epub ahead of print 8 April 2021. DOI: 10.1177/11297298211008103.
23.
D’AndreaVBaroneGPezzaL, et al. Securement of central venous catheters by subcutaneously anchored suturless devices in neonates. J Matern Fetal Neonatal Med. Epub ahead of print 9 May 2021. DOI: 10.1080/14767058.2021.1922377
24.
SpagnuoloF. Global use of ultrasound in newborn vascular access: Ra.Ce.Va: implantation and management of complications. J Ultrasound. Epub ahead of print 1 September 2023. DOI: 10.1007/s40477-023-00813-4.
25.
BreschanCGrafGArneitzC, et al. Feasibility of the ultrasound-guided supraclavicular cannulation of the brachiocephalic vein in very small weight infants: a case series. Paediatr Anaesth2020; 30(8): 928–933.
26.
BresciaFPittirutiMOstroffM, et al. Rapid femoral vein assessment (RaFeVA): a systematic protocol for ultrasound evaluation of the veins of the lower limb, so to optimize the insertion of femorally inserted central catheters. J Vasc Access2021; 22(6): 863–872.
27.
NifongTPMcDevittTJ.The effect of catheter to vein ratio on blood flow rates in a simulated model of peripherally inserted central venous catheters. Chest2011; 140: 48–53.
28.
LampertiMBodenhamARPittirutiM, et al. International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med2012; 38(7): 1105–1117.
29.
CelliniMBergadanoACrocoliA, et al. Guidelines of the Italian Association of Pediatric Hematology and Oncology for the management of the central venous access devices in pediatric patients with onco-hematological disease. J Vasc Access. 2021 May; 22(3):344–352. DOI: 10.1177/1129729820969309.
30.
CrocoliATorneselloAPittirutiM, et al. Central venous access devices in pediatric malignancies: a position paper of Italian Association of Pediatric Hematology and Oncology. J Vasc Access2015; 16(2): 130–136.
31.
BaroneGD’AndreaVVentoG, et al. A systematic ultrasound evaluation of the diameter of deep veins in the Newborn: results and implications for clinical practice. Neonatol2019; 115(4): 335–340.
32.
YokoeDSAndersonDJBerenholtzSM, et al. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals: 2014 updates. Infect Control Hosp Epidemiol2014; 35(8): 967–977.
33.
LovedayHPWilsonJAPrattRJ, et al. epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect2014; 86(Suppl 1): S1–70.
34.
JohnsonJBrackenRTammaPD, et al. Trends in chlorhexidine use in US neonatal intensive care units: results from a follow-up national survey. Infect Control Hosp Epidemiol2016; 37(9): 1116–1118.
35.
WendelDMezoffEARaghuVK, et al. Management of central venous access in children with intestinal failure: a position paper from the NASPGHAN intestinal rehabilitation special interest group. J Pediatr Gastroenterol Nutr2021; 72: 474–486.
36.
GrassoFCapassoAPacellaD, et al. Ultrasound guided catheter tip location in neonates: a prospective cohort study. J Paediatric2022; 244: 86–91.
37.
BaroneGPittirutiMAncoraG, et al. Centrally inserted central catheters in preterm neonates with weight below 1500g by ultrasound-guided access to the brachio-cephalic vein. J Vac Access 2021 May; 22(3):344–352.
38.
FroehlichCDRigbyMRRosenbergES, et al. Ultrasound-guided central venous catheter placement decreases complications and decreases placement attempts compared with the landmark technique in patients in a pediatric intensive care unit. Crit Care Med2009; 37(3): 1090–1096.
39.
Oulego-ErrozIGonzález-CortesRGarcía-SolerP, et al. Ultrasound-guided or landmark techniques for central venous catheter placement in critically ill children. Intensive Care Med2018; 44: 61–72.
40.
Oulego-ErrozIFernández-GarcíaAÁlvarez-JuanB, et al. Ultrasound guided supraclavicular cannulation of the brachiocephalic vein may reduce central line-associated blood- stream infection in preterm infants. Eur J Pediatr2020; 179(11): 1655–1663.
41.
HabasFBaleineJMilésiC, et al. Supraclavicular catheterization of the brachiocephalic vein: a way to prevent or reduce catheter maintenance-related complications in children. Eur J Pediatr2018; 177: 451–459.
42.
RaffaeleASegalARomanoP, et al. Intracavitary electrocardiography-guided positioning of central vascular access device can spare unnecessary ionizing radiation exposure in pediatric patients. J Vasc Access2021; 22(1): 64–68.
43.
PittirutiMPelagattiFPinelliF.Intracavitary electrocardiography for tip location during central venous catheterization: a narrative review of 70 years of clinical studies. J Vasc Access2021; 22(5): 778–785.
44.
PittirutiMBertolloDBrigliaE, et al. The intracavitary ECG method for positioning the tip of central venous catheters: results of an Italian multicenter study. J Vasc Access2012; 13: 357–365.
45.
PittirutiMScoppettuoloG (eds). Manuale GAVeCeLT dei PICC e dei midline. 1st ed. Milan: Edra SpA, 2016, pp. 1–240.
46.
LawsonBTZealleyIA.Adult ‘PICC’ device may be used as a tunneled central venous catheter in children. Cardiovasc Intervent Radiol2018; 41(4): 645–652.
47.
TsaiMHLienRWangJW, et al. Complication rates with central venous catheters inserted at femoral and non-femoral sites in very low birth weight infants. Pediatr Infect Dis J2009; 28(11): 966–970.
48.
Sze YongTVijayanathanAAChungE, et al. Comparing catheter related bloodstream infection rate between cuffed tunnelled and non-cuffed tunnelled peripherally inserted central catheter. J Vasc Access. Epub ahead of print 13 January 2021. DOI: 10.1177/1129729820987373.
49.
BernasconiFZanaboniCDatoA, et al. Atypical use of PICC in infants and small children: a unicentric experience. J Vasc Access2017; 18(6): 535–539.
50.
PittirutiM.The “off-label” use of PICCs. In: SandrucciSMussaB (eds) Peripherally inserted central venous catheters. 1st ed. Milan: Springer/Verlag, 2014, pp.127–144.
51.
PinelliFPittirutiMVan BoxtelT, et al. GAVeCeLT- WoCoVA consensus on subcutaneously anchored securement devices for the securement of venous catheters: current evidence and recommendations for future research. J Vasc Access2021; 22(5): 716–725.
52.
CrocoliAMartucciCSidroL, et al. Safety and effective- ness of subcutaneously anchored securement for tunneled central catheters in oncological pediatric patients: a retrospective study. J Vasc Access. Epub ahead of print 4 June 2021. DOI: 10.1177/11297298211009364.
53.
BainbridgePBrowningPBernatchezSF, et al. Comparing test methods for moisture-vapor transmission rate (MVTR) for vascular access transparent semipermeable dressings. J Vasc Access2021. Epub ahead of print 8 October 2021. DOI: 10.1177/11297298211050485.
54.
WilkinsonJNSheikhNJayamahaJ.Tissue adhesive as an alternative to sutures for securing central venous catheters. Anaesthesia2007; 62(9): 969–970.
55.
Di PuccioFGiacomarroDMatteiL, et al. Experimental study on the chemico-physical interaction between a two-component cyanoacrylate glue and the material of PICCs. J Vasc Access2018; 19(1): 58–62.
56.
LagoP.Neonatal procedural pain management (vol II). Front Paediatr2023; 11: 1270055.
57.
StevensBJohnstonCPetryshenP, et al. Premature Infant Pain Profile: development and initial validation. Clin J Pain1996; 12(1): 13–22.
58.
HummelPPuchalskiMCreechSD, et al. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol2008; 28(1): 55–60.
59.
MermelLAAllonMBouzaE, et al. Clinical practice guide- lines for the diagnosis and management of intravascular catheter-related infection: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis2009; 49(1): 1–45.
60.
ReyCAlvarezFDe La RuaV, et al. Mechanical complications during central venous cannulations in pediatric patients. Intensive Care Med2009; 35(8): 1438–1443.
61.
AlexandrouESpencerTRFrostSA, et al. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates: a report from 13 years of service. Crit Care Med2014; 42(3): 536–543.
62.
PayneNRCarpenterJHBadgerGJ, et al. Marginal increase in cost and excess length of stay associated with nosocomial bloodstream infections in surviving very low birth weight infants. Pediatrics2004; 114(2): 348–355.
63.
StollBJHansenNIAdams-ChapmanI, et al. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA2004; 292(19): 2357–2365.
64.
WheaterMRennieJM.Perinatal infection is an important risk factor for cerebral palsy in very-low-birthweight infants. Dev Med Child Neurol2000; 42: 364–367.
65.
PronovostP.Interventions to decrease catheter-related bloodstream infections in the ICU: the keystone intensive care unit project. Am J Infect Control2008; 36(10): S171. e1–S171.e5.
66.
SmuldersCAvan GestelJPBosAP.Are central line bundles and ventilator bundles effective in critically ill neonates and children?Intensive Care Med2013; 39: 1352–1358.
67.
MatysiakKSzewczukMSobockiJ, et al. Complications of tunneled peripherally inserted and tunneled-cuffed central catheters in home parenteral nutrition. Nutrition2021; 91–92: 111354.
68.
TaylorJEMcDonaldSJEarnestA, et al. A quality improvement initiative to reduce central line infection in neonates using checklists. Eur J Pediatr2017; 176: 639–646
69.
SpagnuoloFVacchianoT.Ultrasound-guided cannulation of the brachiocephalic vein in newborns: a novel approach with a supraclavicular view for tip navigation and tip location. J Vasc Access2022; 23(4): 515–523.
