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.

Study Overview

• Status: Completed
• Conditions: Pediatric Anesthesia; Comparison of 3 Peripheral Vascular Access
• Intervention / Treatment: Other: Ultrasound-guided approach to peripheral vascular access

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Success rate	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

Outcome Measure	Measure Description	Time Frame
The number of attempts	the number of attempts is defined by the number of puncture performed	one hour
The duration of the puncture procedure	the duration of the puncture procedure is defined for the puncture until objectivization of a blood reflux.	on hour
The operator satisfaction	Level of satisfaction of the operators according to the technique used	one hour

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound guidance; Vascular access; Pediatric anesthesia
• Other Study ID Numbers: 9420; 2013-A01587-38 (Registry Identifier: ID RCB)