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

NCT ID: NCT04984967

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Newborns Neonatology Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
Peripheral venous catheterization is perform by a nurse. The placement characteristics are evaluated by the investigator, blind of the condition of placement if possible.

Study Groups

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Insertion of peripheral venous catheter with micro-guide

Group Type EXPERIMENTAL

Insertion of peripheral venous catheter with micro-guide

Intervention Type 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.

Classic insertion of peripheral venous catheter, without micro-guide

Group Type OTHER

Classic insertion of peripheral venous catheter, without micro-guide

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles CAMBONIE

Role: CONTACT

04 67 33 65 56

Vincent BRODEAU

Role: CONTACT

04 67 33 66 09

Facility Contacts

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Vincent BRODEAU, MD

Role: primary

467336609 ext. +33

Other Identifiers

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RECHMPL20_0410

Identifier Type: -

Identifier Source: org_study_id

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