Clinical trial NCT05284422: Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.
Official title: Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Related Complication
Keywords: peripheral
ultrasound-guided
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 376
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to the traditional or ultrasound-guided insertion group
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between 0 and 18 years
* Patients in need of a peripheral venous catheter

Exclusion Criteria:

* Inability of insertion in both forearms (i.e. burnt, amputation)
* Patients in need of a central venous catheter

Primary outcomes:
measure: Number of participants presenting peripheral catheter insertion-related complications for each intervention
timeFrame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Secondary outcomes:
measure: Demographic traits of participants presenting peripheral catheter-related complications
timeFrame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
measure: The proportion of canalization aspects in peripheral catheter-related complications
timeFrame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
measure: Number of participants that present immobilization of the limb in both techniques
timeFrame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
measure: Use of the catheter inserted in participants presenting peripheral catheter-related complications
timeFrame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.