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Femoral Central Venous Access Comparison of 2 Methods

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02318940
Enrollment
99
Registered
2014-12-17
Start date
2014-12-31
Completion date
2016-05-31
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child

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

DEVICEcentral venous catheter

installation of Central venous catheter ultrasound guided

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 15 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Installation on the First Tryintraoperative, an average of 1 hourPercentage of Participants with successful installation on the first transcutaneous passage of the glass needle

Secondary

MeasureTime frameDescription
Successful Installationintraoperative, an average of 1 hourPercentage of participants with successful installation of guide without difficulty in the femoral vein
Number of Attemptsintraoperative, an average of 1 hourNumber of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.
Arterial Punctureintraoperative, an average of 1 hourPercentage of participants with Arterial puncture aspiration

Countries

Chile

Participant flow

Participants by arm

ArmCount
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
Total99

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studylost the record10

Baseline characteristics

CharacteristicLandmark MethodUltrasound MethodTotal
Age, Continuous12 months14 months13 months
Sex: Female, Male
Female
22 Participants22 Participants44 Participants
Sex: Female, Male
Male
27 Participants28 Participants55 Participants
weight10 kg9 kg10 kg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 490 / 50
serious
Total, serious adverse events
0 / 490 / 50

Outcome results

Primary

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

ArmMeasureValue (NUMBER)
Landmark MethodInstallation on the First Try18 percentage of participants
Ultrasound MethodInstallation on the First Try42 percentage of participants
Secondary

Arterial Puncture

Percentage of participants with Arterial puncture aspiration

Time frame: intraoperative, an average of 1 hour

ArmMeasureValue (NUMBER)
Landmark MethodArterial Puncture25 percentage of participants
Ultrasound MethodArterial Puncture10 percentage of participants
Secondary

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

ArmMeasureGroupValue (NUMBER)
Landmark MethodNumber of Attemptsfirst attempt9 participants
Landmark MethodNumber of Attemptssecond attempt4 participants
Landmark MethodNumber of Attemptsthird attempt6 participants
Landmark MethodNumber of Attemptsfourth attempt2 participants
Landmark MethodNumber of Attemptsfifth attempt4 participants
Landmark MethodNumber of AttemptsUnsuccessful cannulation24 participants
Ultrasound MethodNumber of Attemptsfifth attempt0 participants
Ultrasound MethodNumber of Attemptsfirst attempt21 participants
Ultrasound MethodNumber of Attemptsfourth attempt0 participants
Ultrasound MethodNumber of Attemptssecond attempt18 participants
Ultrasound MethodNumber of AttemptsUnsuccessful cannulation7 participants
Ultrasound MethodNumber of Attemptsthird attempt4 participants
Secondary

Successful Installation

Percentage of participants with successful installation of guide without difficulty in the femoral vein

Time frame: intraoperative, an average of 1 hour

ArmMeasureValue (NUMBER)
Landmark MethodSuccessful Installation51 percentage of participants
Ultrasound MethodSuccessful Installation84 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026