Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Incidence of infection of midline catheter
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Incidence of infection of midline catheter
Time Frame: 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 Outcomes
- Body Mass Index(Baseline)
- Identification of intravenous treatments - Corticosteroid(Everyday from baseline, up to 28 days)
- Identification of the germs responsible for infections of midline catheter(Catheter removal, performed up to 28 days after enrollment)
- Lifetime of catheter(Catheter removal, performed up to 28 days after enrollment)
- Incidence of thrombosis(Catheter removal, performed up to 28 days after enrollment)
- Patient comfort(Every three days from baseline, up to 28 days)
- White blood cells count(Everyday from baseline, up to 28 days)
- Duration of insertion procedure(Baseline)
- Identification of intravenous treatments - Antibiotics(Everyday from baseline, up to 28 days)
- Identification of intravenous treatments - Chemotherapy(Everyday from baseline, up to 28 days)
- Identification of intravenous treatments - Nutrient solution(Everyday from baseline, up to 28 days)