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

Not Applicable

Completed

• Conditions: Comparison of 3 Peripheral Vascular Access; Pediatric Anesthesia
• Interventions: Other: Ultrasound-guided approach to peripheral vascular access

• Registration Number: NCT02483507
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T: transversal	Ultrasound-guided approach to peripheral vascular access	Implementation of the vascular catheter with transversal approach under ultrasound guidance
Group L: longitudinal	Ultrasound-guided approach to peripheral vascular access	Implementation of the vascular catheter with longitudinal approach under ultrasound guidance
Group O: oblique	Ultrasound-guided approach to peripheral vascular access	Implementation of the vascular catheter with oblique approach under ultrasound guidance

Primary Outcome Measures

Name	Time	Method
Success rate	one hour	The success of the procedure is defined by the success of the puncture to the first or the second attempt.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Lapeyronie - Département Anesthésie Réanimation A; 🇫🇷 Montpellier, France