Clinical trial NCT02318940: Femoral Central Venous Access Comparison of 2 Methods
Official title: Comparison of Effectiveness and Safety of Two Methods for Installing Femoral Central Venous Catheters in Pediatric Intensive Care Units : Anatomical Method vs Ultrasound in Real Time.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Keywords: ultrasound guided
femoral vein
central venous catheter
pediatric
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 99
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Need for central venous access

Exclusion Criteria:

* More than 15 years.
* Local infection at the puncture site
* Anatomical and / or functional vascular alteration known

Primary outcomes:
measure: Installation on the First Try
timeFrame: intraoperative, an average of 1 hour
Secondary outcomes:
measure: Successful Installation
timeFrame: intraoperative, an average of 1 hour
measure: Number of Attempts
timeFrame: intraoperative, an average of 1 hour
measure: Arterial Puncture
timeFrame: intraoperative, an average of 1 hour
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Exequiel González Cortés
city: Santiago
country: Chile
facility: Hospital Roberto del Rio
Study officials:
affiliation: University of Chile
name: Pietro F Pietroboni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Roberto del Río
name: Cristian Carvajal, MD, Mg
role: STUDY_DIRECTOR
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