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

NCT ID: NCT05284422

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Catheter Related Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to the traditional or ultrasound-guided insertion group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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

Study Groups

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Traditional technique

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.

Group Type ACTIVE_COMPARATOR

Traditional Peripheral venous catheter insertion

Intervention Type PROCEDURE

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

Ultrasound-guided technique

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

Group Type EXPERIMENTAL

Ultrasound-guided insertion of a peripheral venous catheter

Intervention Type PROCEDURE

Insertion of a short catheter in a peripheral vein with the help of an ultrasound device

Interventions

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Traditional Peripheral venous catheter insertion

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

Intervention Type PROCEDURE

Ultrasound-guided insertion of a peripheral venous catheter

Insertion of a short catheter in a peripheral vein with the help of an ultrasound device

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jesus Corrionero, Nurse

Role: CONTACT

+34616559445

Facility Contacts

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Jesus Corrionero, Nurse

Role: primary

+34934893100 ext. 3609

References

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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.

Reference Type BACKGROUND
PMID: 29258474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30196798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22409596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31785409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19262420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31862530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24684163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26953509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25600063 (View on PubMed)

Other Identifiers

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PR(AMI)24/2021

Identifier Type: -

Identifier Source: org_study_id

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