Intensive Care, Neonatology, Newborns
Conditions
Keywords
Newborn infant, Intensive care, vascular access, Peripheral intravenous catheterization
Brief summary
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.
Interventions
DEVICEInsertion of peripheral venous catheter with micro-guide
After 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.
OTHERClassic insertion of peripheral venous catheter, without micro-guide
After antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Peripheral venous catheterization is perform by a nurse. The placement characteristics are evaluated by the investigator, blind of the condition of placement if possible.
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of peripheral venous catheterization at the first attempt | Up to 5 minutes after the success of the placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of the technique | Up to 4 days. | Assessed by the number of venipuncture attempts. |
| Adverse events | Up to 4 days. | Specifically associated with the micro-guide: section, intravascular migration, venous transfixion. |
Countries
France
Contacts
Primary ContactGilles CAMBONIE
Backup ContactVincent BRODEAU
Outcome results
None listed