Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.

Catheter Related Complication Clinical Trial

Official title:

Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284422
• Other study ID #: PR(AMI)24/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Jesus Corrionero, Nurse
• Phone: +34616559445
• Email: jcorrionero[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication

Intervention

Procedure:
• Traditional Peripheral venous catheter insertion
Insertion of a short catheter in a peripheral vein with the help of visualization palpation
• Ultrasound-guided insertion of a peripheral venous catheter
Insertion of a short catheter in a peripheral vein with the help of an ultrasound device

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. Erratum in: BMC Pediatr. 2018 Sep 24;18(1):307. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Salleras-Duran L, Fuentes-Pumarola C, Bosch-Borràs 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. — View 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. — View 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;19:15. doi: 10.1186/s13054-014-0733-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The proportion of canalization aspects in peripheral catheter-related complications	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
Secondary	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
Secondary	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