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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04984967
Other study ID # RECHMPL20_0410
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2021
Est. completion date March 2025

Study information

Verified date June 2024
Source University Hospital, Montpellier
Contact Gilles CAMBONIE
Phone 04 67 33 65 56
Email g-cambonie@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date March 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Insertion 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.
Other:
Classic 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.

Locations

Country Name City State
France University Hospital Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 5 minutes after the success of the placement
Secondary Efficiency of the technique Assessed by the number of venipuncture attempts. Up to 4 days.
Secondary 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). Up to 4 days.
Secondary Efficiency of the technique Assessed by the requirement to insert a central venous line directly linked to failure of peripheral venous catheterization. Up to 4 days.
Secondary 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). Up to 4 days.
Secondary Adverse events Specifically associated with the micro-guide: section, intravascular migration, venous transfixion. Up to 4 days.
Secondary Adverse events Common to the placement of any peripheral venous catheter, regardless of the insertion technique : puncture of an artery, pain, hemorrhage at the puncture site, phlebitis, thrombosis, infection, obstruction and subcutaneous diffusion of the infusion. Up to 1 month.
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