Trials / Completed
CompletedNCT02986542
Comparison of Success Rates of Femoral Artery Catheterization
Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Kahramanmaras Sutcu Imam University · Academic / Other
- Sex
- All
- Age
- 1 Day – 28 Days
- Healthy volunteers
- Accepted
Summary
The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages. This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.
Detailed description
The research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique (Group B). The intervention will be performed by a single experienced individual. The preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1. Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS 1. Local infection 2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES) 1\. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. Preparation duration, number of punctures, complications developing during the procedure
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Femoral artery catheterization | The intervention will be performed by a single experienced individual. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-03-25
- Completion
- 2018-04-02
- First posted
- 2016-12-08
- Last updated
- 2018-04-03
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02986542. Inclusion in this directory is not an endorsement.