Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology

Intensive Care Clinical Trial

— EASYCATH  

Official title:

Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984967
• Other study ID #: RECHMPL20_0410
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: August 2024

Study information

• Verified date: January 2023
• Source: University Hospital, Montpellier
• Contact: Gilles CAMBONIE
• Phone: 04 67 33 65 56
• Email: g-cambonie[@]chu-montpellier.fr
• Is FDA regulated: No
• 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: August 2024
• Est. primary completion date: February 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.

Related Conditions & MeSH terms

• Intensive Care
• Neonatology
• Newborns

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.