Child
Conditions
Keywords
ultrasound guided, femoral vein, central venous catheter, pediatric
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
Interventions
installation of Central venous catheter ultrasound guided
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Installation on the First Try | intraoperative, an average of 1 hour | Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Installation | intraoperative, an average of 1 hour | Percentage of participants with successful installation of guide without difficulty in the femoral vein |
| Number of Attempts | intraoperative, an average of 1 hour | Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts. |
| Arterial Puncture | intraoperative, an average of 1 hour | Percentage of participants with Arterial puncture aspiration |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Landmark Method installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
central venous catheter: installation of Central venous catheter landmark guided | 49 |
| Ultrasound Method installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
central venous catheter: installation of Central venous catheter ultrasound guided | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | lost the record | 1 | 0 |
Baseline characteristics
| Characteristic | Landmark Method | Ultrasound Method | Total |
|---|---|---|---|
| Age, Continuous | 12 months | 14 months | 13 months |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
| weight | 10 kg | 9 kg | 10 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
Installation on the First Try
Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle
Time frame: intraoperative, an average of 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Landmark Method | Installation on the First Try | 18 percentage of participants |
| Ultrasound Method | Installation on the First Try | 42 percentage of participants |
Arterial Puncture
Percentage of participants with Arterial puncture aspiration
Time frame: intraoperative, an average of 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Landmark Method | Arterial Puncture | 25 percentage of participants |
| Ultrasound Method | Arterial Puncture | 10 percentage of participants |
Number of Attempts
Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.
Time frame: intraoperative, an average of 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Landmark Method | Number of Attempts | first attempt | 9 participants |
| Landmark Method | Number of Attempts | second attempt | 4 participants |
| Landmark Method | Number of Attempts | third attempt | 6 participants |
| Landmark Method | Number of Attempts | fourth attempt | 2 participants |
| Landmark Method | Number of Attempts | fifth attempt | 4 participants |
| Landmark Method | Number of Attempts | Unsuccessful cannulation | 24 participants |
| Ultrasound Method | Number of Attempts | fifth attempt | 0 participants |
| Ultrasound Method | Number of Attempts | first attempt | 21 participants |
| Ultrasound Method | Number of Attempts | fourth attempt | 0 participants |
| Ultrasound Method | Number of Attempts | second attempt | 18 participants |
| Ultrasound Method | Number of Attempts | Unsuccessful cannulation | 7 participants |
| Ultrasound Method | Number of Attempts | third attempt | 4 participants |
Successful Installation
Percentage of participants with successful installation of guide without difficulty in the femoral vein
Time frame: intraoperative, an average of 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Landmark Method | Successful Installation | 51 percentage of participants |
| Ultrasound Method | Successful Installation | 84 percentage of participants |