Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?

February 19, 2018 updated by: University Hospital, Montpellier
Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions is likely to cause failures of puncture and complications. The development of ultrasound allowed to "see" the structures to achieve, whether before a puncture or in live for guiding the procedure. Visualization of vessels and adjacent structures has logically resulted in larger cases to a greater security of catheterization, improving the success rate, and decreasing complications. Several positions of the probe can be used to guide a puncture under ultrasound: the transversal approach in short axis, the long axis longitudinal approach and the oblique view approach.The aim of the study was to compare these three different ultrasound-guided approaches to peripheral vascular access in children. All children weighing less than 30 kg that should benefit from the introduction of an arterial catheter or central venous catheter introduced through a peripheral vein are eligible. Patients will be included after parent's and children's information and consent. The choice of the technique used (transverse, longitudinal or oblique approach) is determined by a randomization table.The puncture procedure is performed according to the usual protocols of the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is required for the identification and implementation of the catheter. The position of the probe is dictated by the result of randomization and the Seldinger technique is used for the establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered as a failure. The anesthetist then uses the alternative technique of his choice. All anesthetists participating in this study exercised their main activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally inserted central catheter and arterial catheter is part of the current activity of the unit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • Montpellier, France, 34295
        • Hôpital Lapeyronie - Département Anesthésie Réanimation A

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Child requiring the implementation of a peripherally inserted central catheter or an arterial catheter.
  2. Child whose general state corresponds to the Physical status score I - IV
  3. Child whose weight is lower to 30 kg
  4. Child whose parents will have given their informed consent.
  5. Child affiliated to a national insurance scheme

Exclusion Criteria:

  1. Child presenting a contraindication to the general anesthesia
  2. Child whose weight is upper to 30 kg
  3. Child whose parents did not give their informed consent

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group T: transversal
Implementation of the vascular catheter with transversal approach under ultrasound guidance
Other: Ultrasound-guided approach to peripheral vascular access
the transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture
Active Comparator: Group L: longitudinal
Implementation of the vascular catheter with longitudinal approach under ultrasound guidance
Other: Ultrasound-guided approach to peripheral vascular access
the transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture
Active Comparator: Group O: oblique
Implementation of the vascular catheter with oblique approach under ultrasound guidance
Other: Ultrasound-guided approach to peripheral vascular access
the transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: one hour
The success of the procedure is defined by the success of the puncture to the first or the second attempt.
one hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of attempts
Time Frame: one hour
the number of attempts is defined by the number of puncture performed
one hour
The duration of the puncture procedure
Time Frame: on hour
the duration of the puncture procedure is defined for the puncture until objectivization of a blood reflux.
on hour
The operator satisfaction
Time Frame: one hour
Level of satisfaction of the operators according to the technique used
one hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9420
  • 2013-A01587-38 (Registry Identifier: ID RCB)

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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