Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorUniversity Hospital, Montpellier
About this trial
Peripheral venous catheterization represents the preferential option for term or preterm infant care in order to start drug treatment or hydration, or perform anesthesia.
However, the peripheral venous access is associated in approximately 50% of cases with a failure of the insertion on the first attempt in an emergency context. Using a micro-guide may facilitate the peripheral venous catheterization in newborns, by guiding the catheter in the vein and, thereby reduce the risk of transfixion of the vascular lumen.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
Disqualifiers
Term neonate > 28 days
Premature neonate > 41 weeks of corrected gestational age
Exclusive requirement for an umbilical venous catheter, in the context of neonatal resuscitation
Exclusive requirement for an epicutaneous-cava catheter, in the context of prolonged parenteral nutrition.
Trial design
Design model
Parallel
Treatments tested in this trial
Insertion of peripheral venous catheter with micro-guide
DeviceAfter antisepsis, the vein is punctured using a needle. Then the micro-guide is inserted to the first landmark, which indicates the passage of the micro-guide beyond the end of the needle. After the needle removed, the peripheral venous catheter is placed on the micro-guide. The guide is then removed, the peripheral venous catheter can be used.
Classic insertion of peripheral venous catheter, without micro-guide
Other interventionAfter antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Insertion of peripheral venous catheter with micro-guideExperimental treatment 1 intervention
Group B: Classic insertion of peripheral venous catheter, without micro-guideOther 1 intervention
Trial outcomes
Primary outcomes
1
Success of peripheral venous catheterization at the first attempt
The success of the placement is defined by the arrival of blood in the transparent chamber downstream of the needle during the placement, and by the absence of painful reaction and edema near the insertion site, indicating extravasation or extravascular passage, after flushing the catheter with 0.5 to 1 ml of isotonic saline. The success will be confirmed by retesting flush after securing the peripheral venous catheter in a dressing, within 3 to 5 minutes of successful puncture.
Time frame
Up to 5 minutes after the success of the placementSecondary outcomes
1
Efficiency of the technique
Assessed by the number of venipuncture attempts.
Time frame
Up to 4 days.2
Efficiency of the technique
Assessed by the duration of the installation (time from the end of skin asepsis to the end of the occlusive dressing).
Time frame
Up to 4 days.3
Efficiency of the technique
Assessed by the requirement to insert a central venous line directly linked to failure of peripheral venous catheterization.
Time frame
Up to 4 days.4
Efficiency of the technique
Assessed by the reason for removal of peripheral venous catheter (ie, elective removal or removal for the occurrence of adverse events, see below).
Time frame
Up to 4 days.Sponsors and contacts
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Source ClinicalTrials.gov