Vascular Access Complications
Conditions
Brief summary
Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Several strategies and devices have been employed to decrease the risk for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access and vascular closure devices. Randomized trial data has failed to demonstrate that fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis data has demonstrated that vascular closure devices decrease time to arterial hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do not reduce the incidence of vascular complications as compared to hemostasis achieved with manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the purpose of decreasing vascular access complications has not been examined in a randomized study to date. The present study is a 552 patient randomized controlled clinical trial that will help determine whether femoral arterial access obtained using the Micropuncture Kit will reduce the incidence of vascular access complications compared to the standard 18 gauge needle. The specific aim of this proposal is to compare the rate of femoral artery access complications using the Micropuncture Kit vs. standard femoral artery access. It is our hypothesis that the incidence of femoral artery access complications will be lower among patients in whom the Micropuncture Kit is used.
Interventions
DEVICEMicropuncture Access
Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.
Sponsors
North Texas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing left heart or peripheral catheterization through the common femoral artery with anticipated or possible percutaneous coronary or peripheral intervention
Exclusion criteria
1. Arterial access obtained through the radial or brachial artery 2. Age less than 18 years 3. Patients with known bleeding diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial perforation | 30 days | — |
| Acute limb ischemia | 30 days | Acute limb ischemia, indicated by thrombosis or loss of distal pulses |
| Arteriovenous fistula | 30 days | Arteriovenous fistula, defined as an abnormal communication between an artery and a vein |
| Access site pseudoaneurysm | 30 days | — |
| Retroperitoneal bleeding | 30 days | Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space |
| Groin hematoma | 30 days | Groin hematoma, defined as hematoma \>5 cm. |
| Femoral artery dissection | 30 days | Femoral artery dissection confirmed by angiography |
Countries
United States
Outcome results
None listed