Central Venous Catheter vs Midline in Difficulty Access Patient - A Randomized Controlled Clinical Pilot Trial - Pilot-ACCESS-D

Intravenous access is a necessity for nearly all inpatient medical care. Approximately half of hospitalized patients require a peripheral venous catheter (PVC), either to enable administration of medications intravenously or to repeatedly draw blood samples (1). Establishing a venous access sometimes requires repeated attempts, resulting in multiple needle sticks and prolonged discomfort for patients. In addition, this may lead to a diminished healthcare experience and create a stressful situation for both patients and healthcare personnel (2, 3). Delays in establishing intravenous access can result in setbacks in sample collection and drug administration (4, 5).

Difficult Intravenous Access (DIVA) is a situation that arises "when two or more clinicians fail two or more times to establish a peripheral access using conventional techniques, when a patient lacks visible or palpable veins or the patient has a stated or documented history of DIVA" (6). The prevalence of DIVA varies from 6% to 88% in different studies, primarily due to variations in definition of DIVA. Known risk factors are diabetes, intravenous drug abuse, sex (higher risk for women), chronic illness, obesity, malnutrition, absence of visible or palpable veins (7, 8). Although it is possible to establish a short, standard-length PVC through the help of ultrasound-guidance, this approach has limited scientific support (4, 9-11). In addition, ultrasound-guided PVCs are not health economically justifiable (12).

There are a handful of alternatives in terms of vascular access devices (VAD) for DIVA patients: Standard short PVC, Midline catheter, Central Venous Catheter (CVC) and Peripherally Inserted Central Catheter (PICC). A Midline is a long (8-12 cm), peripherally inserted venous catheter that is most commonly inserted into the upper arm via the basilic, cephalic or brachial veins, with its tip terminating below the level of the axilla (13). A Central Venous Catheter (CVC) is inserted through one of several veins (subclavian, jugular, or femoral) and terminates in a central vein, typically the superior vena cava, right atrium, or the iliac/inferior vena cava, depending on the insertion site. A PICC is an extended venous catheter inserted peripherally, similar to the Midline, inserted through the veins of the upper arm. However, the PICC terminates centrally, in the superior vena cava. There is some existing evidence supporting that Midline catheters could be safer compared to PICCs in short term (14-16). Today, CVCs are standard of care in many centers, but retrospective data indicate that Midlines could be a feasible option in DIVA patients (17). Furthermore, CVC insertion involves certain risks, such as arterial puncture, hematoma or pneumothorax (18). For DIVA patients in need of venous access for 5 days or more, Midlines are preferred as per the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) guidelines (13). However, there are no randomized controlled clinical trials comparing Midlines to CVCs in DIVA patients.

Primary aim of study The aim of the study is to test the feasibility of the study protocol before a future large-scale RCT.