Clinical trial NCT02483507: Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?
Official title: Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anesthesia
Comparison of 3 Peripheral Vascular Access
Keywords: Ultrasound guidance
Vascular access
Pediatric anesthesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success rate
timeFrame: one hour
Secondary outcomes:
measure: The number of attempts
timeFrame: one hour
measure: The duration of the puncture procedure
timeFrame: on hour
measure: The operator satisfaction
timeFrame: one hour
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A
Study officials:
affiliation: Montpellier University Hospital
name: Chrystelle CS SOLA, MD
role: PRINCIPAL_INVESTIGATOR
References: