Prospective Analysis of Incidence and Risk Factors 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.

Official Title
-----------------
Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter

Conditions
-----------------
Intravascular Device

Intervention / Treatment
-----------------
* Device: Midline catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midline catheter<br> | Device: Midline catheter<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |