Femoral Central Venous Access Comparison of 2 Methods
Condition: Child
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness and safety of the installation of
      femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark
      method
    

Detailed description: 
      STUDY DESIGN Multicenter prospective randomized study in pediatric intensive care units of
      the Roberto del Rio's hospital and Exequiel González Cortés' hospital. Patients from entering
      the study between the months of January/2015 to December/2015, after signing informed by
      their parents or legal guardian consent, this will be implemented by the resident

      PATIENTS Previous studies report an average success rate of 50% on the first attempt in the
      anatomical method, both children and adults. Sample size is determined to improve on a 30%
      success rate using the ultrasound method. For a power of 80% in relation to success at the
      first attempt and with a confidence level of 95%, a total of 50 patients per branch is
      determined.

      Method of randomization Using computer program the patient leaving 50 patients in the group
      with the anatomical method, and 50 patients in the ultrasound method are randomized .

      OPERATOR Both installation landmark and ultrasound guidance will be performed by 3 or 4 team
      doctors resident in each center , who count on ≥ 3 years of experience in ICU and training in
      ultrasound-guided access .

      DEFINITIONS

        -  Successful cannulation: is considered successful installation when the guide is
           installed without difficulty in femoral vein.

        -  Cannulation the first try: is considered successful when installing the CVC is
           accomplished by first transcutaneous passage to the glass needle .

        -  Attempt to cannulation: considered attempt the passage of the needle without removing or
           redirect moving forward. Each successive removal or redirection with a forward motion is
           considered more a try.

        -  Arterial puncture: Arterial puncture aspiration involves pulsatile arterial blood .

        -  Rescue: After the fifth attempt in the landmark method will change the method under
           ultrasound guidance and is considered not successful cannulation. Result of not having
           puncture site is changed.

      INSTALLATION METHOD

        -  Anatomical : In supine with external rotation and abduction of the lower extremity is
           located by palpating the femoral artery in the femoral triangle and punctured medial to
           this towards the navel to have reflux of venous blood.

        -  Guided by ultrasound: Ultrasound is performed to verify the presence and proper position
           of a target vessel before puncturing the skin followed by real-time ultrasound to guide
           the needle tip during the lancing process.

      OUTCOME It was considered as primary outcome main installation on the first try , and
      secondary outcome cannulation success, number of attempts and , as a complication of the
      procedure, arterial puncture. Rescue will be used after the 5th attempt in the anatomical
      method that will change the method under ultrasound guidance . Failure to gain access shall
      be considered as successful cannulation and change of puncture site

      STATISTICAL ANALYSIS For statistical analysis the Stata 12.0 software was used. Continuous
      variables were analyzed using descriptive analysis of normal distribution with means and
      standard deviations , and continuous variables were not normally distributed and qualitative
      medians and percentiles. For the primary outcome will be used to varying dicomtómic Chi
      square method
    

Intervention name(s): central venous catheter; central venous catheter
Intervention type(s): Device; Device
Intervention description(s): installation of Central venous catheter ultrasound guided; installation of Central venous catheter landmark guided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ultrasound guided; femoral vein; central venous catheter; pediatric