NewbornsEASYCATHNCT04984967
Interest of Peripheral Venous Catheter Insertion Using a Micro-guide in Neonatology
A study testing Insertion of peripheral venous catheter with micro-guide and Classic insertion of peripheral venous catheter, without micro-guide in people with Newborns and Neonatology, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Newborns, Neonatology, Intensive Care
- What is being tested?
- Insertion of peripheral venous catheter with micro-guide and Classic insertion of peripheral venous catheter, without micro-guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Montpellier
Montpellier, 34295
Vincent BRODEAU, MD, 467336609 ext. +33, v-brodeau@chu-montpellier.fr
About this study
Official title: Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
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
- Being tested
- Insertion of peripheral venous catheter with micro-guide, Classic insertion of peripheral venous catheter, without micro-guide
- Keywords
- Newborn infant, Intensive care, vascular access, Peripheral intravenous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of peripheral venous catheter with micro-guideDevice
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-guideOther
After antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.
| Study group | Role | What they receive |
|---|---|---|
| Insertion of peripheral venous catheter with micro-guide | Experimental | Not described Receives: Device: Insertion of peripheral venous catheter with micro-guide |
| Classic insertion of peripheral venous catheter, without micro-guide | Other | Not described Receives: Other: Classic insertion of peripheral venous catheter, without micro-guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 minutes after the success of the placement
Secondary outcomes (6)
Efficiency of the technique
Assessed by the number of venipuncture attempts.
Measured: Up to 4 days.
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).
Measured: Up to 4 days.
Efficiency of the technique
Assessed by the requirement to insert a central venous line directly linked to failure of peripheral venous catheterization.
Measured: Up to 4 days.
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).
Measured: Up to 4 days.
Adverse events
Specifically associated with the micro-guide: section, intravascular migration, venous transfixion.
Measured: Up to 4 days.
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.
Measured: Up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start8 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984967
- Sponsor's protocol ID
- RECHMPL20_0410
- Acronym
- EASYCATH
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Peripheral Venous Catheterization in Newborns : Insertion on Micro-guide Versus Conventional Insertion, Without Micro-guide
- ClinicalTrials.gov ID
- NCT04984967
- Acronym / sponsor ID
- EASYCATH / RECHMPL20_0410
- Conditions
- Newborns, Neonatology, Intensive Care
- Keywords
- Newborn infant, Intensive care, vascular access, Peripheral intravenous catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn admitted in the department of neonatal medicine and pediatric intensive care, at Montpellier University Hospital
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of peripheral venous catheter with micro-guideAfter 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. | Device | Insertion of peripheral venous catheter with micro-guide |
| Classic insertion of peripheral venous catheter, without micro-guideAfter antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place. | Other | Classic insertion of peripheral venous catheter, without micro-guide |
Primary outcome
Success of peripheral venous catheterization at the first attempt
Time frame: 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.
6 secondary outcomes
Efficiency of the technique
Time frame: Up to 4 days.
Efficiency of the technique
Time frame: Up to 4 days.
Efficiency of the technique
Time frame: Up to 4 days.
Efficiency of the technique
Time frame: Up to 4 days.
Adverse events
Time frame: Up to 4 days.
Adverse events
Time frame: Up to 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of peripheral venous catheter with micro-guide and Classic insertion of peripheral venous catheter, without micro-guide in people with Newborns and Neonatology, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles CAMBONIE (04 67 33 65 56, g-cambonie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of peripheral venous catheterization at the first attempt (time frame: Up to 5 minutes after the success of the placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.