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The purpose of this study is to compare the appearance of complications after the insertion of peripheral venous catheters with two different techniques (traditional and ultrasound-guided).
All patients, whose parents were informed about the study and give written informed consent, will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to visualization/palpation or ultrasound-guided peripheral catheter insertion. All participants undergo a 10 days monitoring of the catheter status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional technique | Active Comparator | Peripheral venous catheters inserted to the participants in this arm are inserted with a palpation/visualization guided technique in their hand, arm, foot or head. |
|
| Ultrasound-guided technique | Experimental | Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Peripheral venous catheter insertion | Procedure | Insertion of a short catheter in a peripheral vein with the help of visualization palpation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants presenting peripheral catheter insertion-related complications for each intervention | Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic traits of participants presenting peripheral catheter-related complications | Age average (years) and gender (male/female) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days |
| The proportion of canalization aspects in peripheral catheter-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesus Corrionero, Nurse | Contact | +34616559445 | jcorrionero@vhebron.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29258474 | Background | Ben Abdelaziz R, Hafsi H, Hajji H, Boudabous H, Ben Chehida A, Mrabet A, Boussetta K, Barsaoui S, Sammoud A, Hamzaoui M, Azzouz H, Tebib N. Peripheral venous catheter complications in children: predisposing factors in a multicenter prospective cohort study. BMC Pediatr. 2017 Dec 19;17(1):208. doi: 10.1186/s12887-017-0965-y. | |
| 30196798 |
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The name and location (ward/room) of participants will be accessible to researchers until the peripheral catheter withdrawal.
From the insertion to the withdrawal of the peripheral venous catheter.
Investigator will access individual participant data to monitor and register the catheter condition
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Participants are assigned to the traditional or ultrasound-guided insertion group
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A random list is generated by a computer randomizer program. Sealed numbered envelopes are prepared with study documents and the technique to be performed. Investigators take envelops in consecutive order as long as participants accept to be included in the study
| Ultrasound-guided insertion of a peripheral venous catheter | Procedure | Insertion of a short catheter in a peripheral vein with the help of an ultrasound device |
|
Catheter size (Ga), operator experience (years), insertion site (hand/forearm/arm/foot/head), insertion ward (PICU/ER) |
| From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days |
| Number of participants that present immobilization of the limb in both techniques | Immobilization of the limb where the peripheral catheter is inserted (Yes/No) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days |
| Use of the catheter inserted in participants presenting peripheral catheter-related complications | Type of fluid infusion, antibiotic administration (Yes/No) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days |
| Carr PJ, Rippey JCR, Cooke ML, Higgins NS, Trevenen M, Foale A, Rickard CM. From insertion to removal: A multicenter survival analysis of an admitted cohort with peripheral intravenous catheters inserted in the emergency department. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1216-1221. doi: 10.1017/ice.2018.190. Epub 2018 Sep 10. |
| 22409596 | Background | Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12. |
| 31785409 | Background | Suliman M, Saleh W, Al-Shiekh H, Taan W, AlBashtawy M. The Incidence of Peripheral Intravenous Catheter Phlebitis and Risk Factors among Pediatric Patients. J Pediatr Nurs. 2020 Jan-Feb;50:89-93. doi: 10.1016/j.pedn.2019.11.006. Epub 2019 Nov 27. |
| 19262420 | Background | Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946. |
| 31862530 | Background | Indarwati F, Mathew S, Munday J, Keogh S. Incidence of peripheral intravenous catheter failure and complications in paediatric patients: Systematic review and meta analysis. Int J Nurs Stud. 2020 Feb;102:103488. doi: 10.1016/j.ijnurstu.2019.103488. Epub 2019 Nov 26. |
| 24684163 | Background | Cicolini G, Manzoli L, Simonetti V, Flacco ME, Comparcini D, Capasso L, Di Baldassarre A, Eltaji Elfarouki G. Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi-centre prospective study. J Adv Nurs. 2014 Nov;70(11):2539-49. doi: 10.1111/jan.12403. Epub 2014 Mar 31. |
| 26953509 | Background | Salleras-Duran L, Fuentes-Pumarola C, Bosch-Borras N, Punset-Font X, Sampol-Granes FX. Ultrasound-Guided Peripheral Venous Catheterization in Emergency Services. J Emerg Nurs. 2016 Jul;42(4):338-43. doi: 10.1016/j.jen.2015.11.005. Epub 2016 Mar 4. No abstract available. |
| 25600063 | Background | Takeshita J, Nakayama Y, Nakajima Y, Sessler DI, Ogawa S, Sawa T, Mizobe T. Optimal site for ultrasound-guided venous catheterisation in paediatric patients: an observational study to investigate predictors for catheterisation success and a randomised controlled study to determine the most successful site. Crit Care. 2015 Jan 20;19(1):15. doi: 10.1186/s13054-014-0733-4. |