Catheter Complications
Conditions
Keywords
Ultrasound guided intravenous access, vascular access, extended dwell catheter, IV survival
Brief summary
In patients with difficult IV access, ultrasound-guided catheter insertion is a preferred technique. However, many peripheral catheters fail and must be replaced, adding extra pain and difficulty for the patient, and requiring more healthcare provider time to maintain. In preliminary studies, we determined that catheters which extend further into the vein have a smaller failure rate. This study will compare two lengths of catheters to see if the longer catheters have better survival in a population of patients who have difficult IV access. Patients will be randomized to receive a standard length or extra-long venous catheter, which will be monitored daily for functionality during the patient's hospital course.
Detailed description
Patients with poor intravenous (IV) access present a daily challenge to emergency department (ED) practitioners. Placement of an ultrasound (US)-guided peripheral IV catheter in this patient population is a viable and safe option. Ultrasound-guided IVs are often the last recourse for IV access before resorting to more invasive procedures in patients with difficult access. Successful cannulation with US-guided IV occurs in more than 90% of cases compared with 25-35% with traditional IV placement in patients with difficult vascular access. Once cannulated, however, the failure rate of IV catheters placed under ultrasound guidance is concerning compared with traditional blind IV placement. Overall failure rates after successful IV cannulation for US-guided IVs is 45-56% when compared to traditional IV placement which is 19-25%. Because failure rate is high, it is important to approach insertions methodically to improve survival rates. A variable that may alter the survival of US-guided IVs that has not been studied is the length of catheter that resides in the vein. Currently the general accepted rule is that an adequate amount of the catheter should be in the vein to avoid failure of the catheter. Our preliminary data focused on defining this relationship. In our study, 100% of catheters failed in which less than 30% of the catheter was placed within the vein and no failures in those IVs in which at least 65% of the catheter was in the vein. This study was performed by the PI at Beaumont this past year and is published in Emergency Medicine Journal. This study is a prospective randomized controlled study of catheter longevity comparing a 4.78 cm (1.88 in) catheter to a longer 6.35 cm (2.5 in) catheter. Subjects will consist of a convenience sample of patients with difficult IV access presenting to the Beaumont Hospitals emergency department that require US-guided IV access. Standard of care is defined as use of a readily available 1.88 inch IV catheter that is used daily by emergency department personnel. Following consent, patients will be randomized to the control arm using the standard 4.78 cm catheter, or the experimental arm using a 6.35 cm catheter. All catheters are 20 gauge in diameter. After patient enrollment, the insertion tech, nurse or physician who has been credentialed in ultrasound-guided vascular access will place catheters in study subjects. Staff are expected to attempt a minimum of 3 attempts before enlisting another provider for help. After initial assessment, follow-up functionality of the catheter will be assessed every 24 hours by the research team as long as the patient is hospitalized, up to 30 days. Function of the catheter will be assessed daily by research staff. Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Other data variables collected include: patient pertinent medical history, vitals, age, sex, cannulation success or failure, vein diameter, length of catheter in vein as well as % length of the catheter in the vein, angle of insertion, number of venous access attempts, time to IV insertion (tourniquet to tegaderm), location of IV insertion, medications infused or use for ionic contrast injection for computed tomography.
Interventions
DEVICEStandard Long IV 4.78 cm 20 g catheter
Standard Long IV 4.78 cm 20 g catheter
DEVICEUltra-Long IV 6.35 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheter
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years or older Self-reported difficult IV Access Patient and any one of the following: * Greater than 2 sticks in previous admission/hospital encounter * History of rescue vascular access device (such as US-guided IV, PICC line, midline, or CVC) * End-stage renal disease on dialysis * History of IV Drug Use * History of Sickle Cell Disease
Exclusion criteria
Age under 18 years old * Voluntary withdrawal or refusal to participate * Previous enrollment into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of IV Survival | 30 days | Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis | 30 days | Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients |
| Infection | 30 days | Number of patient with infection as defined as the patient meeting the laboratory-confirmed bloodstream infection criteria as defined by the Centers for Disease Control. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Long IV 4.78 cm 20 g Catheter Placement of Standard Long IV 4.78 cm 20 g catheter
Standard Long IV 4.78 cm 20 g catheter: Standard Long IV 4.78 cm 20 g catheter | 126 |
| Ultra-Long IV 6.35 cm 20 g Catheter Placement of Ultra-Long length IV 6.35 cm 20 g catheter
Ultra-Long IV 6.35 cm 20 g catheter: Ultra-Long IV 6.35 cm 20 g catheter | 131 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Duplicate Enrollment | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Ultra-Long IV 6.35 cm 20 g Catheter | Total | Standard Long IV 4.78 cm 20 g Catheter |
|---|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 18.2 | 59.2 years STANDARD_DEVIATION 17.8 | 58.2 years STANDARD_DEVIATION 18.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 131 participants | 257 participants | 126 participants |
| Sex: Female, Male Female | 92 Participants | 184 Participants | 92 Participants |
| Sex: Female, Male Male | 39 Participants | 73 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 131 |
| other Total, other adverse events | 0 / 126 | 0 / 131 |
| serious Total, serious adverse events | 0 / 126 | 0 / 131 |
Outcome results
Primary
Duration of IV Survival
Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Long IV 4.78 cm 20 g Catheter | Duration of IV Survival | 92 hours |
| Ultra-Long IV 6.35 cm 20 g Catheter | Duration of IV Survival | 136 hours |
Secondary
Infection
Number of patient with infection as defined as the patient meeting the laboratory-confirmed bloodstream infection criteria as defined by the Centers for Disease Control.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Long IV 4.78 cm 20 g Catheter | Infection | 0 Participants |
| Ultra-Long IV 6.35 cm 20 g Catheter | Infection | 0 Participants |
Secondary
Thrombosis
Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Long IV 4.78 cm 20 g Catheter | Thrombosis | 0 Participants |
| Ultra-Long IV 6.35 cm 20 g Catheter | Thrombosis | 0 Participants |