Study of the Prevalence of Midline Replacements and the Reasons for These Replacements

Overview

Venous access management plays a key role in patient care and preserving their venous capital. The so-called "conventional" peripheral venous catheter is the most common venous access device, but it is associated with a high rate of complications, particularly in cases of prolonged use or poor venous capital. Recommendations, such as those from MAGIC or SF2H, advocate their use when the intended duration of use is 5 days or less. For longer periods or in cases of difficult access, so-called "central" devices such as PICC lines or central venous catheters are used, although they present specific risks such as CLASBI or deep vein thrombosis. In intermediate situations, the midline, a peripheral venous access device, is a relevant alternative, particularly for non-venotoxic intravenous treatments lasting more than 5 days. Although it is theoretically associated with fewer infections and complications than the PICCline, its complication rate and actual duration of use vary widely in the literature. The MAGIC recommendations suggest using them for periods of 14 days or less. The widespread use of midlines in healthcare facilities, and in particular the creation of vascular access units, has given rise to issues shared between centers, notably the replacement rate of these devices. The study therefore aims to determine the replacement and early removal rates for midlines, the circumstances in which they are replaced, and toassess the relevance of the 28-day limit in the choice of device, in order to improve practices and optimize the practitioner's initial decision.

Primary outcome measures

• Evaluate the midline replacement rate regardless of the indication, in the various requesting centers [Time frame: within 28 days after the initial placement of the midline]

Secondary outcome measures (5)

• Secondary objective 1: To evaluate the early removal rate among patients living with midlines within 28 days of placement. [Time frame: over a censored period of 28 days]
• Secondary objective 2: Describe the reasons for early removal of midlines. [Time frame: Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days]
• Secondary objective 3: Describe the lifespan of midlines [Time frame: This duration includes the number of days between the day of inclusion and the day of device removal over a censored period of 28 days.]
• Secondary objective 4: Describe the replacement rate of midlines among midlines still in place at different time [Time frame: Days 7, 14, 21 and 28]
• Secondary objective 5: Compare the midline replacement rate between the initial indication of antibiotic therapy and the initial indication of insufficient venous capacity [Time frame: Replacements taken into account occur over a censored period of 28 days beginning on the day of inclusion]

Eligibility criteria

Inclusion criteria

• Patients over 18 years of age.
• Patients who have given their consent to participate in the study.
• Patients treated in a hospital unit authorized to insert midlines, or who have a midline inserted by a professional trained in this procedure, in accordance with the local organization of each center.
• First insertion for the treatment of a given event with an expected treatment duration of 28 days or less.
• Patients treated with a midline catheter at least 14 cm in length.

Exclusion criteria

• No coverage by the social security system
• Failure to insert the midline
• Patient under guardianship or conservatorship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Centre Hospitalier de Valenciennes — Valenciennes

Identifiers

NCT: NCT07394296 · 2025-03-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗