Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
NCT Number: NCT04409418
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Royal Oak, Michigan, 48073, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Corewell Health East
Other
Blood Sampling and Extended Dwell Catheters: A Randomized Trial of Blood Sampling Functionality Based on Site Selection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04469218
IV Catheter-Related Infection or Complication
Hartford, Connecticut, United States
View Trial DetailsNCT05911451
Arteriovenous Fistula, Arteriovenous Graft
Alkmaar, Netherlands
View Trial DetailsNCT05741866
Cardiovascular Diseases, Catheter Complications
Herston, Queensland, Australia
View Trial DetailsNCT02513303
Arteriovenous Fistula, Arteriovenous Malformations
Huntsville, Alabama, United States
View Trial Details