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

NCT04984967 | Recruiting DMC

• 1 other identifier: RECHMPL20_0410
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborns; Neonatology; Intensive Care

Keywords

Newborn infant; Intensive care; vascular access; Peripheral intravenous catheterization

Outcome Measures

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.

  Up to 5 minutes after the success of the placement

Secondary Outcomes (6)

• Efficiency of the technique

  Up to 4 days.

• Efficiency of the technique

  Up to 4 days.

• Efficiency of the technique

  Up to 4 days.

• Efficiency of the technique

  Up to 4 days.

• Adverse events

  Up to 4 days.

Study Arms (2)

Insertion of peripheral venous catheter with micro-guide

EXPERIMENTAL

Device: Insertion of peripheral venous catheter with micro-guide

Classic insertion of peripheral venous catheter, without micro-guide

OTHER

Other: Classic insertion of peripheral venous catheter, without micro-guide

Interventions

Insertion of peripheral venous catheter with micro-guide DEVICE

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.

Insertion of peripheral venous catheter with micro-guide

Classic insertion of peripheral venous catheter, without micro-guide OTHER

After antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.

Classic insertion of peripheral venous catheter, without micro-guide

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, 34295, France

RECRUITING

Central Study Contacts

Gilles CAMBONIE

CONTACT

04 67 33 65 56; g-cambonie@chu-montpellier.fr

Vincent BRODEAU

CONTACT

04 67 33 66 09; v-brodeau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Peripheral venous catheterization is perform by a nurse. The placement characteristics are evaluated by the investigator, blind of the condition of placement if possible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: August 2, 2021
• Study Start: December 8, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)