Intravascular Device
Conditions
Brief summary
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.
Interventions
DEVICEMidline catheter
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.
Sponsors
TIMC-IMAG
Vygon GmbH & Co. KG
Groupe Hospitalier Mutualiste de Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infection of midline catheter | Catheter removal, performed up to 28 days after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of intravenous treatments - Corticosteroid | Everyday from baseline, up to 28 days | Determination of whether corticosteroid are intravenously administered during the day (YES/NO). |
| Identification of intravenous treatments - Antibiotics | Everyday from baseline, up to 28 days | Determination of whether antibiotics are intravenously administered during the day (YES/NO). |
| Identification of intravenous treatments - Chemotherapy | Everyday from baseline, up to 28 days | Determination of whether chemotherapy was intravenously administered during the day (YES/NO). |
| Identification of intravenous treatments - Nutrient solution | Everyday from baseline, up to 28 days | Determination of whether nutrient solution was intravenously administered during the day (YES/NO). |
| Duration of insertion procedure | Baseline | — |
| Identification of the germs responsible for infections of midline catheter | Catheter removal, performed up to 28 days after enrollment | For each infected catheter, the species name of the germ responsible for the infection will be collected. |
| Body Mass Index | Baseline | — |
| White blood cells count | Everyday from baseline, up to 28 days | — |
| Incidence of thrombosis | Catheter removal, performed up to 28 days after enrollment | If the catheter is no more permeable, a doppler echocardiography will be done to confirm the diagnosis of thrombosis. |
| Patient comfort | Every three days from baseline, up to 28 days | 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. |
| Lifetime of catheter | Catheter removal, performed up to 28 days after enrollment | Time from catheter insertion to catheter removal, measured in days. |
Countries
France
Outcome results
None listed