Intravascular Device Clinical Trial
— TIM-GHMOfficial title:
Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
| Verified date | December 2019 |
| Source | Groupe Hospitalier Mutualiste de Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | October 21, 2019 |
| Est. primary completion date | October 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age superior or equal to 18 years old - Intravascular treatment planned for more than 6 days Exclusion Criteria: - Medical history of mastectomy with bilateral lymphadenectomy - Peripheral neuropathy - Upper-Extremity Deep Vein Thrombosis - Arteriovenous fistula - Poor condition of the skin of the upper limbs - Patient in palliative care - Patient in emergency care - Patient under guardianship/curatorship - Pregnant or breastfeeding women |
| Country | Name | City | State |
|---|---|---|---|
| France | Groupe Hospitalier Mutualiste de Grenoble | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier Mutualiste de Grenoble | TIMC-IMAG, Vygon GmbH & Co. KG |
France,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Identification of intravenous treatments - Corticosteroid | Determination of whether corticosteroid are intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days | |
| Secondary | Identification of intravenous treatments - Antibiotics | Determination of whether antibiotics are intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days | |
| Secondary | Identification of intravenous treatments - Chemotherapy | Determination of whether chemotherapy was intravenously administered during the day (YES/NO). | Everyday from baseline, up to 28 days | |
| Secondary | 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 | |
| Secondary | Duration of insertion procedure | Baseline | ||
| Secondary | Lifetime of catheter | Time from catheter insertion to catheter removal, measured in days. | Catheter removal, performed up to 28 days after enrollment | |
| Secondary | Body Mass Index | Baseline | ||
| Secondary | White blood cells count | Everyday from baseline, up to 28 days | ||
| Secondary | 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 | |
| Secondary | 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 |