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| Name | Class |
|---|---|
| TIMC-IMAG | OTHER |
| Vygon GmbH & Co. KG | INDUSTRY |
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The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at or below the level of the axilla. It is a relevant alternative to other catheters in case of limited venous access and long-run perfusions. Moreover, another significant advantage may be the reduction of the risk of infection.
However, the Midline catheter is poorly described in scientific literature, essentially through retrospective and meta analyses including multiple types of catheters (Piccline, CVC, PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in case of the Midline catheter.
The results of this study could bring a collective benefit in terms of knowledge and reliability of these intravascular devices.
Depending on these results, a randomized, controlled study will be considered, in order to compare the Midline catheter to its main alternative : the Piccline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midline catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midline catheter | Device | The catheter will be inserted according to usual practices, after the enrollment of the patient in the study. The follow-up will last until the removal of the catheter, which will also be done according to usual practices. Following the removal, bacteriologic analyses will be performed in order to diagnose any prospective infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection of midline catheter | The method used for bacteriologic analyses will be the Brun Buisson Technique. The diagnosis of infection of the catheter will be based on the clinical signs, the catheter bacteriology, the blood culture collected on the patient and the blood culture collected on the catheter. | Catheter removal, performed up to 28 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the germs responsible for infections of midline catheter | For each infected catheter, the species name of the germ responsible for the infection will be collected. | Catheter removal, performed up to 28 days after enrollment |
| Identification of intravenous treatments - Corticosteroid |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Mutualiste de Grenoble | Grenoble | 38028 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9601314 | Background | Goetz AM, Miller J, Wagener MM, Muder RR. Complications related to intravenous midline catheter usage. A 2-year study. J Intraven Nurs. 1998 Mar-Apr;21(2):76-80. | |
| 24440542 | Background | Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17. |
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|
Determination of whether corticosteroid are intravenously administered during the day (YES/NO). |
| Everyday from baseline, up to 28 days |
| Identification of intravenous treatments - Antibiotics | Determination of whether antibiotics are intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days |
| Identification of intravenous treatments - Chemotherapy | Determination of whether chemotherapy was intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days |
| Identification of intravenous treatments - Nutrient solution | Determination of whether nutrient solution was intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days |
| Duration of insertion procedure | Baseline |
| Lifetime of catheter | Time from catheter insertion to catheter removal, measured in days. | Catheter removal, performed up to 28 days after enrollment |
| Body Mass Index | Baseline |
| White blood cells count | Everyday from baseline, up to 28 days |
| Incidence of thrombosis | If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis. | Catheter removal, performed up to 28 days after enrollment |
| Patient comfort | Numeric rating scale will be collected for each of these 3 dimensions : comfort when eating, comfort when moving, comfort for personal hygiene The scale will range from 0 to 10. 0 will mean "very uncomfortable" and 10 will mean "very comfortable". | Every three days from baseline, up to 28 days |
| 21906266 | Background | Timsit JF, Dubois Y, Minet C, Bonadona A, Lugosi M, Ara-Somohano C, Hamidfar-Roy R, Schwebel C. New materials and devices for preventing catheter-related infections. Ann Intensive Care. 2011 Aug 18;1:34. doi: 10.1186/2110-5820-1-34. |
| 22947496 | Background | Ugas MA, Cho H, Trilling GM, Tahir Z, Raja HF, Ramadan S, Jerjes W, Giannoudis PV. Central and peripheral venous lines-associated blood stream infections in the critically ill surgical patients. Ann Surg Innov Res. 2012 Sep 4;6(1):8. doi: 10.1186/1750-1164-6-8. |
| 25331552 | Background | Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21. |
| 24811591 | Background | Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25. |
| 7486466 | Background | Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995 Dec 1;123(11):841-4. doi: 10.7326/0003-4819-123-11-199512010-00005. |
| 23295565 | Background | Pongruangporn M, Ajenjo MC, Russo AJ, McMullen KM, Robinson C, Williams RC, Warren DK. Patient- and device-specific risk factors for peripherally inserted central venous catheter-related bloodstream infections. Infect Control Hosp Epidemiol. 2013 Feb;34(2):184-9. doi: 10.1086/669083. Epub 2012 Dec 14. |