Study of the Prevalence of Midline Replacements and the Reasons for These Replacements
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier de Valenciennes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No coverage by the social security system
Failure to insert the midline
Patient under guardianship or conservatorship
Trial population
Patients included in the study are those whose midline indication has been validated by the vascular access unit according to the hospital's organization. The expected duration of midline use should be 28 days or less.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the midline replacement rate regardless of the indication, in the various requesting centers
The primary endpoint is the cumulative incidence rate of midline replacement over a censored period of 28 days. This period begins on the day of inclusion with the first midline placement, regardless of the indication. Competing events are removal without replacement, regardless of the cause (death, removal at the end of treatment, early removal before the end of treatment without replacement).
Time frame
within 28 days after the initial placement of the midlineSecondary outcomes
1
Secondary objective 1: To evaluate the early removal rate among patients living with midlines within 28 days of placement.
Cumulative incidence rate of early removal of midlines placed on the day of inclusion over a censored period of 28 days. Competing events are death and removal due to end of treatment
Time frame
over a censored period of 28 days2
Secondary objective 2: Describe the reasons for early removal of midlines.
Midline removal rate for each of the following reasons: * Extravasation/diffusion of the product * Suspected midline infection * Confirmed midline infection * Accidental removal * Catheter-induced deep vein thrombosis * Catheter occlusion * Inability to perform sampling * Conversion to PICCline * Duration exceeded
Time frame
Withdrawals are analyzed from the day of inclusion and over a censored period of 28 days3
Secondary objective 3: Describe the lifespan of midlines
Midline lifespan. The event is the removal of the midline regardless of the cause: removal at the end of treatment, removal due to death, early removal (with or without reinsertion).
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.4
Secondary objective 4: Describe the replacement rate of midlines among midlines still in place at different time
Cumulative incidence rate of midline recurrence with a benchmark at D7, D14, then D21, censored at D28
Time frame
Days 7, 14, 21 and 28Sponsors and contacts
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Source ClinicalTrials.gov