Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil
NCT ID: NCT03719287
Last Updated: 2024-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
295 participants
OBSERVATIONAL
2019-01-07
2019-10-01
Brief Summary
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Detailed Description
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There are no treatments. The short peripheral I.V. catheter-related medical devices (products) observed during the study are currently approved by Brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Hospital #1
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
No interventions assigned to this group
Hospital #2
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
No interventions assigned to this group
Hospital #3
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject admitted into one of the wards audited at the study site;
* Subject available for observation at the time of the audit;
* Subject with at least one inserted PIVC;
* Subject that voluntarily signed and dated the informed consent form (ICF) prior to study entry, if required by the study site's Ethics Committee.
Exclusion Criteria
* Subject admitted into a mental health ward, emergency ward or burn unit;
* Subject awaiting transfer to another facility.
18 Years
ALL
No
Sponsors
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Eurotrials Brasil Consultores Cientificos Ltda
INDUSTRY
3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Joaquim Simoes Neto, MD
Role: PRINCIPAL_INVESTIGATOR
Centro de Pequisa Clinica Sao Lucas
Larissa S Victor, RN
Role: PRINCIPAL_INVESTIGATOR
Hospital Erasto Gaertner (HEG)
Ariane F Machado Avelar, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Hospital Erasto Gaertner (HEG)
Curitiba, Paraná, Brazil
Centro de Pequisa Clinica Sao Lucas
Campinas, São Paulo, Brazil
Universidade Federal de Sao Paulo
São Paulo, , Brazil
Countries
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References
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PR Newswire. Global Peripheral I.V. catheter market 2014-2018.
Rickard CM, Webster J, Wallis MC, Marsh N, McGrail MR, French V, Foster L, Gallagher P, Gowardman JR, Zhang L, McClymont A, Whitby M. Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial. Lancet. 2012 Sep 22;380(9847):1066-74. doi: 10.1016/S0140-6736(12)61082-4.
Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, Hopkins T. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. BMJ. 2008 Jul 8;337(7662):a339. doi: 10.1136/bmj.a339.
Bausone-Gazda D, Lefaiver CA, Walters SA. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. J Infus Nurs. 2010 Nov-Dec;33(6):371-84. doi: 10.1097/NAN.0b013e3181f85be2.
Martinez JA, Piazuelo M, Almela M, Blecua P, Gallardo R, Rodriguez S, Escalante Z, Robau M, Trilla A. Evaluation of add-on devices for the prevention of phlebitis and other complications associated with the use of peripheral catheters in hospitalised adults: a randomised controlled study. J Hosp Infect. 2009 Oct;73(2):135-42. doi: 10.1016/j.jhin.2009.06.031. Epub 2009 Aug 27.
Maki DG. Improving the safety of peripheral intravenous catheters. BMJ. 2008 Jul 8;337(7662):a630. doi: 10.1136/bmj.a630.
Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.
Alexandrou E, Ray-Barruel G, Carr PJ, Frost S, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM. International prevalence of the use of peripheral intravenous catheters. J Hosp Med. 2015 Aug;10(8):530-3. doi: 10.1002/jhm.2389. Epub 2015 Jun 3.
Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
Mattox EA. Complications of Peripheral Venous Access Devices: Prevention, Detection, and Recovery Strategies. Crit Care Nurse. 2017 Apr;37(2):e1-e14. doi: 10.4037/ccn2017657.
Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.
Marsh N, Webster J, Flynn J, Mihala G, Hewer B, Fraser J, Rickard CM. Securement methods for peripheral venous catheters to prevent failure: a randomised controlled pilot trial. J Vasc Access. 2015 May-Jun;16(3):237-44. doi: 10.5301/jva.5000348. Epub 2015 Feb 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EM-05-014222
Identifier Type: -
Identifier Source: org_study_id
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