Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil

NCT03719287 | Completed Results DMC

• 1 other identifier: EM-05-014222
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 3

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.

Conditions

Infusion Site Injury

Outcome Measures

Primary Outcomes (1)

• Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)

  Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical complication ÷ Number of audited PIVC sites) x 100

  From PIVC insertion to the audit, up to 7 days.

Secondary Outcomes (4)

• Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).

  From PIVC insertion to the audit, up to 7 days.

• Percentage of PIVC Sites With at Least One Clinical Complication

  From PIVC insertion to the audit, up to 7 days.

• Percentage of PIVC Sites With at Least One Mechanical Complication

  From PIVC insertion to the audit, up to 7 days.

• Percentage of PIVC Sites With at Least One Related Quality Issue

  From PIVC insertion to the audit, up to 7 days.

Study Arms (3)

Hospital #1

Patients who meet inclusion criteria in the first of three participating Brazil hospitals

Hospital #2

Patients who meet inclusion criteria in the second of three participating Brazil hospitals

Hospital #3

Patients who meet inclusion criteria in the third of the three participating Brazil hospitals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator
• 3M: collaborator

Study Sites (3)

Hospital Erasto Gaertner (HEG)

Curitiba, Paraná, Brazil

Location

Centro de Pequisa Clinica Sao Lucas

Campinas, São Paulo, 13034-685, Brazil

Location

Universidade Federal de Sao Paulo

São Paulo, Brazil

Location

Related Publications (12)

• PR Newswire. Global Peripheral I.V. catheter market 2014-2018.

  BACKGROUND

• 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.

  PMID: 22998716 BACKGROUND

• 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.

  PMID: 18614482 BACKGROUND

• 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.

  PMID: 21079465 BACKGROUND

• 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.

  PMID: 19712998 BACKGROUND

• Maki DG. Improving the safety of peripheral intravenous catheters. BMJ. 2008 Jul 8;337(7662):a630. doi: 10.1136/bmj.a630.

  PMID: 18614483 BACKGROUND

• 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.

  PMID: 24334800 BACKGROUND

• 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.

  PMID: 26041384 BACKGROUND

• 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.

  PMID: 33394637 BACKGROUND

• 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.

  PMID: 28365664 BACKGROUND

• 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.

  PMID: 25871866 BACKGROUND

• 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.

  PMID: 25656258 BACKGROUND

Results Point of Contact

• Title: Helen Han
• Organization: 3M

mhan3@mmm.com

651-737-9234

Study Officials

• Joaquim Simoes Neto, MD

  Centro de Pequisa Clinica Sao Lucas

  PRINCIPAL INVESTIGATOR

• Larissa S Victor, RN

  Hospital Erasto Gaertner (HEG)

  PRINCIPAL INVESTIGATOR

• Ariane F Machado Avelar, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: October 25, 2018
• Study Start: January 7, 2019
• Primary Completion: July 31, 2019
• Study Completion: October 1, 2019
• Last Updated: October 2, 2024
• Results First Posted: August 2, 2022

Record last verified: 2024-09

Locations

BR (3)