Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter (TIM-GHM)

Groupe Hospitalier Mutualiste de Grenoble

Status: Completed

Conditions: Intravascular Device

Treatments: Device: Midline catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03373630

2017/11-DFO-GHMG

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Midline catheter

Experimental group

Treatment:

Device: Midline catheter