IV Catheter-Related Infection or Complication, Peripheral Venous Access, Vascular Access Complication
Conditions
Keywords
intravenous access, vascular access, IV survival
Brief summary
The purpose of this study is to compare upper arm versus forearm Extended Dwell Catheter (EDC) placement for blood sampling functionality. EDC is an alternative to peripheral Intravenous (IVs) especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Detailed description
Many patients will require ongoing blood draws for laboratory testing while in the hospital and hospitals generally avoid using peripheral IVs for laboratory testing as it is associated with an increase in complications such as irritation and infiltration (where the IV medication or fluid will leak out of the vein and into the surrounding tissue). Therefore, patients are often required to have multiple needlesticks throughout their hospital stay which can lead to patient dissatisfaction and anxiety. Extended dwell catheters (EDC) offer an alternative to peripheral IVs especially during prolonged hospital stays. EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of the elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. While there is not a lot of evidence about how well these catheters will allow blood to be drawn, an EDC can be used to obtain blood for routine blood draws and potentially eliminate the need for additional needle sticks. Eligible patients in this study will be randomized to two groups based on placement site: experimental group (forearm) or the control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. The research team will capture images on the ultrasound machine that is used for initial assessment of sites per routine care. If the vein is appropriate for cannulation based on these assessments, the Advance Practice Provider (APP) will insert the catheter. If the APP on the Vascular Access Team (VAT) has no adequate target visualized in the randomly selected site, the inserter may evaluate another site that is more suitable for cannulation. Functionality will be confirmed by ability to aspirate by drawing back into a syringe and then the catheter flushed with 5cc of normal saline without resistance. The site of insertion will be recorded and pertinent information will be collected similar to other catheter placements. Securement of the placed IV will be standardized between groups. Daily assessment of functionality (patency of the catheter) will be performed by the research team for the life of the catheter while hospitalized (up to 30 days).
Interventions
DEVICEExtended dwell catheters
EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-site, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inpatient Inclusion Criteria: 1. Consult to VAT for vascular access device placement 2. Patient requires peripheral access 3. Adults \>18 years of age ED Patient Inclusion Criteria 1. Age \> 18 years old 2. Difficult vascular access defined as: patient has no visible veins (\>2mm) or palpable veins 3. Anticipated hospital admission All patients meeting inclusion criteria will be pre-scanned prior to formal enrollment to identify diameter of target veins and calculate a catheter to vein ratio at the potential insertion site. Patients must meet this criteria in both upper arm and forearm locations prior to enrollment and randomization.
Exclusion criteria
Patients will be excluded if: 1. Multiple lumens required 2. Functional vascular access device exists proximal to the targeted area of insertion. This does not include superficial non-ultrasound guided peripheral IVs. 3. Upper extremity cannot be accessed due to a coexisting medical condition 4. Cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sampling Functionality | During hospitalization, up to 30 days | Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Dwell Time/Survival | During hospitalization, up to 30 days | Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of hours until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization. |
| Thrombosis | During hospitalization, up to 30 days | The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation. |
Countries
United States
Participant flow
Pre-assignment details
100 were consented. Prior to randomization, 9 patients were excluded for inadequate vessel size, 2 patients withdrew from the study, 1 patient investigator removed due to other IV access. 20 patients originally assigned to the forearm group crossed over to the upper arm group because there was no suitable target vessel, leaving 24 in the forearm group and 64 in the upper arm group.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa.
Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. | 24 |
| Control Group Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa.
Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. | 64 |
| Total | 88 |
Baseline characteristics
| Characteristic | Control Group | Total | Experimental Group |
|---|---|---|---|
| Age, Customized <=25 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Customized 26-50 years | 14 Participants | 18 Participants | 4 Participants |
| Age, Customized 51-75 years | 34 Participants | 47 Participants | 13 Participants |
| Age, Customized >75 years | 15 Participants | 20 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 64 participants | 88 participants | 24 participants |
| Sex: Female, Male Female | 39 Participants | 50 Participants | 11 Participants |
| Sex: Female, Male Male | 25 Participants | 38 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 64 |
| other Total, other adverse events | 6 / 24 | 24 / 64 |
| serious Total, serious adverse events | 0 / 24 | 0 / 64 |
Outcome results
Primary
Blood Sampling Functionality
Blood sampling ability will be evaluated by daily blood draws prior to patient discharge. The measured outcome is number of hours until failure to aspirate blood identified during follow-up assessment during hospitalization.
Time frame: During hospitalization, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Blood Sampling Functionality | 70.19 hours | Standard Deviation 61.41 |
| Control Group | Blood Sampling Functionality | 112.9 hours | Standard Deviation 141.47 |
Secondary
Catheter Dwell Time/Survival
Functionality of catheter for intravenous therapy prior to patient discharge. The measured outcome is number of hours until failure of functionality identified as inability to infuse without resistance during follow-up assessment during hospitalization.
Time frame: During hospitalization, up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Catheter Dwell Time/Survival | 74.27 hours | Standard Deviation 59.9 |
| Control Group | Catheter Dwell Time/Survival | 115.52 hours | Standard Deviation 140.42 |
Secondary
Thrombosis
The number of participants with symptomatic catheter-related upper extremity venous thrombosis (CR-UEVT) inclusive of superficial thrombophlebitis (SVT) and deep venous thrombosis (DVT) confirmed by upper extremity venous duplex evaluation.
Time frame: During hospitalization, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental Group | Thrombosis | 2 Participants |
| Control Group | Thrombosis | 5 Participants |