This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a
coin) controlled trial of catheter failure evaluating the impact of a built-in guide
wire. This study plans to enroll 360 participants (two equally sized groups of 180
participants in each arm). Screening data will be reviewed to determine participant
eligibility. Participants who meet all inclusion criteria and none of the exclusion
criteria will be entered into the study. After study participant enrollment, the
clinician participant is engaged to perform the procedure. Randomization will occur and
placement of the IV will be placed by clinicians who are proficient in ultrasound guided
vascular access. Data regarding placement, technique and clinician experience will be
collected at the time the IV is placed.
A catheter is functional if the clinician participant is able to aspirate blood and/or
flush without resistance with 3-5 milliliters (mL) of saline. Other insertion-related
data variables collected at the time of insertion or retrospectively, include: clinician
participant details, number of insertion attempts, patient pertinent medical history
specifically assessing for history of difficult access on a previous visit, End Stage
Renal Disease (ESRD) on dialysis, IV drug abuse, sickle cell disease, vitals, age, sex,
race, body mass index, first-stick success, cannulation success or failure, vein
diameter, vein depth, number of venous access attempts, time of IV insertion, location of
IV insertion, and distance of IV insertion (skin puncture site) from the crease of the
arm. A venous access attempt is defined as each time the needle punctures the skin.
Movement or adjustment in subcutaneous tissue is not considered an additional attempt
unless the needle is completely withdrawn and reinserted.
Once the IV is placed, follow-ups will be completed beginning the day after enrollment.
Assessments will be conducted in person and/or by communication with the clinical team
nurse to assess functionality, status of IV dressing/dressing changes, and signs/symptoms
of complications. Assessment for complications includes normal appearance, pain, redness,
swelling, induration, appearance of a palpable venous cord at or near IV site. This data
will then be used by the clinical research nurse or Principal Investigator to assess for
phlebitis. Patients will be assessed for clinical phlebitis using a standardized scale
(Table 1). This scale is scored from 0 to 5, 0 being no signs of phlebitis and 5 being
advanced stage of thrombophlebitis.
Daily follow ups will be completed until the IV has been removed or has failed. If the
catheter failed or was removed prior to the follow-up assessment, then the IV failure
time and the assessment of failure and reason for line removal will be obtained through
chart review or through discussion with the participant's care team. The options for
cause of removal include: (1) completion of therapy (2) infiltration (3) infection (4)
dislodgement (5) leaking (6) pain (7) other and (8) unknown. For all failed catheters,
re-insertion attempt data will be tracked through the medical record in the nursing
section for venous lines and need for reinsertion of the IV or escalation to a midline,
peripherally inserted central catheter (PICC), or central venous catheter (CVC) will be
noted. The time interval from removal of failed device to the insertion of a new device
will be noted as the treatment delay interval recorded in hours.
Superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) rates will be
calculated based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic
cases. Pulmonary embolism rates will also be captured based on computed tomography (CT)
chest diagnosis or ventilation perfusion (V/Q) nuclear test result of high probability
for pulmonary embolism. Key personnel approved by Institutional Review Board will review
all study subject records in the electronic medical records system, and screen enrolled
subject data for all upper extremity venous doppler test, chest CTs, and V/Q
examinations. Radiology interpretations will be reviewed for findings consistent with
catheter related upper extremity venous thrombosis or pulmonary embolism. Presence or
absence of thrombosis will be noted. If the patient is diagnosed with thrombophlebitis,
the location of the thrombus will also be documented. This review will account for
thrombosis development up to 30 days post patient discharge. Symptoms and rationale for
imaging will be documented. As long peripheral IVs are inserted into the deep veins of
the arms at times, DVT is a known complication.
Infection rate will be tracked using confirmed catheter-related blood stream infection
data from the surveillance team within the epidemiology department. The team utilizes the
Centers for Disease Control definition of laboratory-confirmed blood-stream infection
(LCBSI).
The medication administration record will be reviewed for anticoagulants and select
irritant and vesicants given through each catheter. Vesicant drugs can result in tissue
necrosis or formation of blisters when accidentally infused into tissue surrounding a
vein. Vesicants that are generally given via central line or considered caustic to the
vessel will be noted in both groups. Number of doses will be recorded.