Venipuncture Clinical Trial
— ALPIVEINEOfficial title:
Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
NCT number | NCT05831605 |
Other study ID # | D20170121 |
Secondary ID | ID-RCB |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2023 |
Est. completion date | May 2024 |
The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins.
Status | Recruiting |
Enrollment | 452 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | Inclusion Criteria - Any child aged at most 44 weeks + 6 days of corrected term hospitalized in neonatal intensive care and neonatology with a medical prescription for a venous blood sample and with visibility and palpability of the vein under 5mm *OR - Any child under the age of 18 in the emergency room with a prescription for a blood test and with visibility and palpability of the vein under 5mm - One parent agreed on their child participation in this study. - Patient with health insurance Exclusion Criteria - Vital emergency which needs a venous route instalment - Parental refusal - Parents who do not speak French - Patient who has already been included in the study - Blood sample taken by a medical student or a nursing student or childcare nurse student. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Trousseau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with first venipuncture attempt | Obtention 0.5 ml of blood | at day 0 | |
Secondary | Successful venepuncture duration | Duration from application of tourniquet to obtention of 0.5 ml of blood at most after the 3rd venepuncture attempt | at day 0 | |
Secondary | Pain evaluation during venipuncture | Using FLACC or DAN (acute pain of the new-born) scale (score 0 to 10, 10 is most painful) at most after the 3rd venepuncture attempt | at day 0 | |
Secondary | Caregivers's opinion | Opinion of caregivers on the ease of use, effectiveness and their general satisfaction, using a small questionary (very unsatisfied, unsatisfied, satisfied, very satisfied) at most after the 3rd venepuncture attempt | at day 0 |
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