Catheter Related ComplicationNCT05284422
Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.
A study testing Traditional Peripheral venous catheter insertion and Ultrasound-guided insertion of a peripheral venous catheter in people with Catheter Related Complication, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- Traditional Peripheral venous catheter insertion and Ultrasound-guided insertion of a peripheral venous catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 0 and 18 years
- Patients in need of a peripheral venous catheter
Who cannot join
- Inability of insertion in both forearms (i.e. burnt, amputation)
- Patients in need of a central venous catheter
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
Jesus Corrionero, Nurse, +34934893100 ext. 3609, jcorrionero@vhebron.net
About this study
Official title: Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.
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).
Read the 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.
- Conditions
- Catheter Related Complication
- Being tested
- Traditional Peripheral venous catheter insertion, Ultrasound-guided insertion of a peripheral venous catheter
- Keywords
- peripheral, ultrasound-guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Peripheral venous catheter insertionProcedure or surgery
Insertion of a short catheter in a peripheral vein with the help of visualization palpation
Ultrasound-guided insertion of a peripheral venous catheterProcedure or surgery
Insertion of a short catheter in a peripheral vein with the help of an ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ultrasound-guided insertion of a peripheral venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants presenting peripheral catheter insertion-related complications for each intervention
Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction
Measured: 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
Age average (years) and gender (male/female)
Measured: 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
Catheter size (Ga), operator experience (years), insertion site (hand/forearm/arm/foot/head), insertion ward (PICU/ER)
Measured: 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)
Measured: 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)
Measured: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to the traditional or ultrasound-guided insertion group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284422
- Sponsor's protocol ID
- PR(AMI)24/2021
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The name and location (ward/room) of participants will be accessible to researchers until the peripheral catheter withdrawal.
Publications
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.
PubMed 29258474Carr 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.
PubMed 30196798Benkhadra 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.
PubMed 22409596Suliman 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.
PubMed 31785409Doniger 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.
PubMed 19262420Indarwati 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.
PubMed 31862530Cicolini 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.
PubMed 24684163Salleras-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.
PubMed 26953509Takeshita 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.
PubMed 25600063
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.
- ClinicalTrials.gov ID
- NCT05284422
- Acronym / sponsor ID
- PR(AMI)24/2021
- Conditions
- Catheter Related Complication
- Keywords
- peripheral, ultrasound-guided
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to the traditional or ultrasound-guided insertion group
| Arm | Type | Receives |
|---|---|---|
| Traditional technique | Active comparator | Procedure: Traditional Peripheral venous catheter insertionPeripheral 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 | Procedure: Ultrasound-guided insertion of a peripheral venous catheterPeripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 0 and 18 years
- Patients in need of a peripheral venous catheter
Key exclusion criteria (2 listed)
- Inability of insertion in both forearms (i.e. burnt, amputation)
- Patients in need of a central venous catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Peripheral venous catheter insertionInsertion of a short catheter in a peripheral vein with the help of visualization palpation | Procedure or surgery | Traditional technique |
| Ultrasound-guided insertion of a peripheral venous catheterInsertion of a short catheter in a peripheral vein with the help of an ultrasound device | Procedure or surgery | Ultrasound-guided technique |
Primary outcome
Number of participants presenting peripheral catheter insertion-related complications for each intervention
Time frame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction
4 secondary outcomes
Demographic traits of participants presenting peripheral catheter-related complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 29258474Ben 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.
- Background: PubMed 30196798Carr 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.
- Background: PubMed 22409596Benkhadra 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.
- Background: PubMed 31785409Suliman 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.
- Background: PubMed 19262420Doniger 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.
- Background: PubMed 31862530Indarwati 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.
- Background: PubMed 24684163Cicolini 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.
- Background: PubMed 26953509Salleras-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.
- Background: PubMed 25600063Takeshita 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.
- Individual participant dataSharing planned: Yes. The name and location (ward/room) of participants will be accessible to researchers until the peripheral catheter withdrawal.
Related trials for Catheter Related Complication
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Not yet recruitingObservational study
Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis
Acute Kidney Injury, Catheter-Related Complications
Recruiting
Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization
Catheter-Associated Urinary Tract Infection, Catheter Related Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Peripheral venous catheter insertion and Ultrasound-guided insertion of a peripheral venous catheter in people with Catheter Related Complication, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesus Corrionero, Nurse (+34616559445, jcorrionero@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants presenting peripheral catheter insertion-related complications for each intervention (time frame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284422, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.