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

NCT05284422 | Unknown

• 1 other identifier: PR(AMI)24/2021
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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).

Conditions

Catheter Related Complication

Keywords

peripheral; ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Demographic traits of participants presenting peripheral catheter-related complications

  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

  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

  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

  From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days

Study Arms (2)

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.

Procedure: Traditional Peripheral venous catheter insertion

Ultrasound-guided technique

EXPERIMENTAL

Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm.

Procedure: Ultrasound-guided insertion of a peripheral venous catheter

Interventions

Traditional Peripheral venous catheter insertion PROCEDURE

Insertion of a short catheter in a peripheral vein with the help of visualization palpation

Traditional technique

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

Ultrasound-guided technique

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related 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.

  PMID: 29258474 BACKGROUND

• 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.

  PMID: 30196798 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.

  PMID: 22409596 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.

  PMID: 31785409 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.

  PMID: 19262420 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.

  PMID: 31862530 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.

  PMID: 24684163 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.

  PMID: 26953509 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.

  PMID: 25600063 BACKGROUND

Central Study Contacts

Jesus Corrionero, Nurse

CONTACT

+34616559445; jcorrionero@vhebron.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to the traditional or ultrasound-guided insertion group

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 17, 2022
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From the insertion to the withdrawal of the peripheral venous catheter.
• Access Criteria: Investigator will access individual participant data to monitor and register the catheter condition

Locations

ES (1)