Femoral Central Venous Access Comparison of 2 Methods

February 12, 2017 updated by: Pietro Pietroboni Fuster, University of Chile

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 8320000
        • Hospital Exequiel Gónzalez Cortés
      • Santiago, Chile, 8320000
        • Hospital Roberto del Rio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: central venous catheter
installation of Central venous catheter ultrasound guided
Device: central venous catheter
installation of Central venous catheter landmark guided
Active Comparator: 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
Device: central venous catheter
installation of Central venous catheter ultrasound guided
Device: central venous catheter
installation of Central venous catheter landmark guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Installation on the First Try
Time Frame: intraoperative, an average of 1 hour
Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle
intraoperative, an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Installation
Time Frame: intraoperative, an average of 1 hour
Percentage of participants with successful installation of guide without difficulty in the femoral vein
intraoperative, an average of 1 hour
Number of Attempts
Time Frame: intraoperative, an average of 1 hour
Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.
intraoperative, an average of 1 hour
Arterial Puncture
Time Frame: intraoperative, an average of 1 hour
Percentage of participants with Arterial puncture aspiration
intraoperative, an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Principal Investigator: Pietro F Pietroboni, MD, University of Chile
  • Study Director: Cristian Carvajal, MD, Mg, Hospital Roberto del Rio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HRR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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