Clinical trial NCT03719287: Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil
Official title: National, Cross-sectional, Multicenter Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil: a Quality Improvement Study (PIVS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infusion Site Injury
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Eurotrials Brasil Consultores Cientificos Ltda
name: 3M
First posted: 2018-10-25
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the wards of the participating acute care hospitals that will be audited in the study. To minimize subject selection bias, all subjects will be identified and invited to participate in the study consecutively, as the auditor screens the ward on the day of the audit.

Brief summary: A multi-center, national prevalence study where: (1) baseline SPIVC therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the Hospital's evidence based practice will be measured in Brazil.

Detailed description: At each participating research site, select nurse clinicians who are experienced or experts in short peripheral I.V. catheter (SPIVC) therapy, will audit medical records and observe the SPIVC sites of adult patients in various hospital wards until a minimum total of 300 SPIVC sites are audited among 3 Brazilian acute care hospitals. The wards audited will be selected by the Investigator and will be audited during a specified time period until at least 100 SPIVCs are audited. The time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required.

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.

Eligibility criteria: Inclusion Criteria:

* Male or female subject, aged 18 years or older at the time of the study's audit of the ward;
* 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 under treatment at the study site's outpatient clinics;
* Subject admitted into a mental health ward, emergency ward or burn unit;
* Subject awaiting transfer to another facility.

Primary outcomes:
measure: Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)
timeFrame: From PIVC insertion to the audit, up to 7 days.
Secondary outcomes:
measure: Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).
timeFrame: From PIVC insertion to the audit, up to 7 days.
measure: Percentage of PIVC Sites With at Least One Clinical Complication
timeFrame: From PIVC insertion to the audit, up to 7 days.
measure: Percentage of PIVC Sites With at Least One Mechanical Complication
timeFrame: From PIVC insertion to the audit, up to 7 days.
measure: Percentage of PIVC Sites With at Least One Related Quality Issue
timeFrame: From PIVC insertion to the audit, up to 7 days.
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner (HEG)
state: Parana
city: Campinas
country: Brazil
facility: Centro de Pequisa Clinica Sao Lucas
state: Sao Paolo
city: São Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
Study officials:
affiliation: Centro de Pequisa Clinica Sao Lucas
name: Joaquim Simoes Neto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Erasto Gaertner (HEG)
name: Larissa S Victor, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Ariane F Machado Avelar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: PR Newswire. Global Peripheral I.V. catheter market 2014-2018.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Maki DG. Improving the safety of peripheral intravenous catheters. BMJ. 2008 Jul 8;337(7662):a630. doi: 10.1136/bmj.a630.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.