An interventional study of Extended dwell catheters in IV Catheter-Related Infection or Complication, Vascular Access Complication and Peripheral Venous Access, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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.
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).
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
This study's enrollment of 100 is below the median of 149 across 84 interventional studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inpatient Inclusion Criteria:
ED Patient Inclusion Criteria
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:
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.
Device: Extended dwell catheters
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.
Device: 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.
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
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
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
| Milestone | Experimental Group | Control Group |
|---|---|---|
| Started | 24 | 64 |
| Completed | 24 | 64 |
| Not completed | 0 | 0 |
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.
| hours | Experimental Group | Control Group |
|---|---|---|
| Blood Sampling Functionality | 70.19 ± 61.41 | 112.9 ± 141.47 |
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.
| hours | Experimental Group | Control Group |
|---|---|---|
| Catheter Dwell Time/Survival | 74.27 ± 59.9 | 115.52 ± 140.42 |
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.
| Participants | Experimental Group | Control Group |
|---|---|---|
| Thrombosis | 2 | 5 |
Collected over During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Group | 0/24 (0%) | 0/24 (0%) | 6/24 (25%) |
| Control Group | 0/64 (0%) | 0/64 (0%) | 24/64 (37.5%) |
| Event | Experimental Group | Control Group |
|---|---|---|
| Catheter occlusionProduct Issues | 3/24 | 13/64 |
| Superficial vein thrombosisVascular disorders | 2/24 | 4/64 |
| InfiltrationSkin and subcutaneous tissue disorders | 1/24 | 3/64 |
| Catheter dislodgementProduct Issues | 1/24 | 3/64 |
| Catheter leakageProduct Issues | 1/24 | 2/64 |
| Deep vein thrombosisVascular disorders | 0/24 | 1/64 |
| Age, Customized(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| <=25 years | 2 | 1 | 3 |
| 26-50 years | 4 | 14 | 18 |
| 51-75 years | 13 | 34 | 47 |
| >75 years | 5 | 15 | 20 |
| Sex: Female, Male(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| Female | 11 | 39 | 50 |
| Male | 13 | 25 | 38 |
| Race and Ethnicity Not Collected(Participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Experimental Group | Control Group | Total |
|---|---|---|---|
| United States | 24 | 64 | 88 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2021 to primary completion in Sep 2023, 27 months.
Results were first posted in Nov 2024, 1 year 1 month after primary completion.
Of 28 non-industry interventional studies with no phase under Catheter-Related Infections, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 36. This study's 27 months is above that.
Counting every sponsor, half of 31 studies reached it within 22 months; a quarter within 13 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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