Skip to main content
OpenTrials
Completed

NCT Number: NCT02483507

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound-guided approach to peripheral vascular access

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. The number of attempts

    Time frame: one hour

    the number of attempts is defined by the number of puncture performed

  2. 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.

  3. The operator satisfaction

    Time frame: one hour

    Level of satisfaction of the operators according to the technique used

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.