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| Name | Class |
|---|---|
| Eurotrials Brasil Consultores Cientificos Ltda | INDUSTRY |
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical 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 and one mechanical complication ÷ Number of audited PIVC sites) x 100 PIVC sites with at least one clinical complication and one mechanical complication as well. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Erasto Gaertner (HEG) | Curitiba | Paraná | Brazil | |||
| Centro de Pequisa Clinica Sao Lucas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | PR Newswire. Global Peripheral I.V. catheter market 2014-2018. | ||
| 22998716 | 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. | |
| 18614482 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospital #1 | Patients who meet inclusion criteria in the first of three participating Brazil hospitals |
| FG001 | Hospital #2 | Patients who meet inclusion criteria in the second of three participating Brazil hospitals |
| FG002 | Hospital #3 | Patients who meet inclusion criteria in the third of the three participating Brazil hospitals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline data was not analyzed per hospital
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospital #1 | Patients who meet inclusion criteria in the first of three participating Brazil hospitals |
| BG001 | Hospital #2 | Patients who meet inclusion criteria in the second of three participating Brazil hospitals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | 95% Confidence Interval | percentage of PIVC sites | From PIVC insertion to the audit, up to 7 days. | PIVC sites | PIVC sites |
|
From PIVC insertion to the audit, up to 7 days.
The country's and/or hospital's formal AE (incident) reporting process was used to document the AE.
PIVC-related AEs corresponding to PIVC-related complications of interest for the study (Section 10.1.2) were documented by study personnel in the corresponding Individual PIVC Questionnaire. Only these events were documented in the eCFR - there was no requirement for any additional information on AEs to be recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospital #1 | Patients who meet inclusion criteria in the first of three participating Brazil hospitals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Han | 3M | 651-737-9234 | mhan3@mmm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2018 | Feb 22, 2021 | Prot_SAP_000.pdf |
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| From PIVC insertion to the audit, up to 7 days. |
| Percentage of PIVC Sites With at Least One Clinical Complication | Specific clinical complications are: phlebitis (grade 1 - 4), Hematoma, Ecchymosis, Skin injury, Local infection. Prevalence (%) = (Number of audited PIVC sites with at least one clinical complication ÷ Number of audited PIVC sites) x 100 | From PIVC insertion to the audit, up to 7 days. |
| Percentage of PIVC Sites With at Least One Mechanical Complication | 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 mechanical complication ÷ Number of audited PIVC sites) x 100 | From PIVC insertion to the audit, up to 7 days. |
| Percentage of PIVC Sites With at Least One Related Quality Issue | Quality Issues are: Unstable PIVC, Blood reflux,Uncontrolled IV infusion rate,Site dressing partially detached, Site dressing totally detached (site exposed to environment), Medical tape added to dressing edges, Unclean dressing, discomfort at insertion site with and without palpation, uncovered tubing access port, lack of visibility at the PIVC site. Prevalence (%) = (Number of audited PIVC sites with at least one related quality issue ÷ Number of audited PIVC sites) x 100 | From PIVC insertion to the audit, up to 7 days. |
| Campinas |
| São Paulo |
| 13034-685 |
| Brazil |
| Universidade Federal de Sao Paulo | São Paulo | Brazil |
| 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. |
| 21079465 | 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. |
| 19712998 | 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. |
| 18614483 | Background | Maki DG. Improving the safety of peripheral intravenous catheters. BMJ. 2008 Jul 8;337(7662):a630. doi: 10.1136/bmj.a630. |
| 24334800 | 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. |
| 26041384 | 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. |
| 33394637 | 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. |
| 28365664 | 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. |
| 25871866 | 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. |
| 25656258 | 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. |
| BG002 | Hospital #3 | Patients who meet inclusion criteria in the third of the three participating Brazil hospitals |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | The Sex/Gender data was not analyzed per hospital | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients who meet inclusion criteria in the second of three participating Brazil hospitals |
| OG002 | Hospital #3 | Patients who meet inclusion criteria in the third of the three participating Brazil hospitals |
|
|
| Secondary | Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical 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 and one mechanical complication ÷ Number of audited PIVC sites) x 100 PIVC sites with at least one clinical complication and one mechanical complication as well. | Posted | Number | 95% Confidence Interval | percentage of PIVC sites | From PIVC insertion to the audit, up to 7 days. | PIVC sites | PIVC sites |
|
|
|
| Secondary | Percentage of PIVC Sites With at Least One Clinical Complication | Specific clinical complications are: phlebitis (grade 1 - 4), Hematoma, Ecchymosis, Skin injury, Local infection. Prevalence (%) = (Number of audited PIVC sites with at least one clinical complication ÷ Number of audited PIVC sites) x 100 | Posted | Number | 95% Confidence Interval | percentage of PIVC sites | From PIVC insertion to the audit, up to 7 days. | PIVC sites | PIVC sites |
|
|
|
| Secondary | Percentage of PIVC Sites With at Least One Mechanical Complication | 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 mechanical complication ÷ Number of audited PIVC sites) x 100 | Posted | Number | 95% Confidence Interval | percentage of PIVC sites | From PIVC insertion to the audit, up to 7 days. | PIVC sites | PIVC sites |
|
|
|
| Secondary | Percentage of PIVC Sites With at Least One Related Quality Issue | Quality Issues are: Unstable PIVC, Blood reflux,Uncontrolled IV infusion rate,Site dressing partially detached, Site dressing totally detached (site exposed to environment), Medical tape added to dressing edges, Unclean dressing, discomfort at insertion site with and without palpation, uncovered tubing access port, lack of visibility at the PIVC site. Prevalence (%) = (Number of audited PIVC sites with at least one related quality issue ÷ Number of audited PIVC sites) x 100 | Posted | Number | 95% Confidence Interval | percentage of PIVC sites | From PIVC insertion to the audit, up to 7 days. |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Hospital #2 | Patients who meet inclusion criteria in the second of three participating Brazil hospitals | 0 | 99 | 0 | 99 | 0 | 99 |
| EG002 | Hospital #3 | Patients who meet inclusion criteria in the third of the three participating Brazil hospitals | 0 | 96 | 0 | 96 | 0 | 96 |
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| Title | Measurements |
|---|---|
|