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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Registry Identifier | 2022-A02584-39 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
This trial aims to evaluate the act of venipuncture with or without the near-infrared light device for any children requiring a venipuncture for a blood sample or for insertion of peripheral venous line in neonatal intensive care and neonatology, and in pediatric emergencies.
For any eligible patient, at least one parent will be approached by a member of the medical or paramedical team trained on the protocol to explain the study to him/her and to be able to include the child during the next venous blood sampling or the insertion of a venous line. In case the parent agrees on the child's participation, the investigator is in charge of obtaining an informed consent.
During the next venous blood sampling or the insertion of a venous line, the nurse responsible for the patient:
To avoid device-related bias, the AccuVein® AV 400 (CE 0086 marking) was chosen. This device uses near infrared light to detect superficial veins under the skin and then projects an image of these veins onto the skin surface, exactly above the veins. The device will be held between 10 and 20 cm perpendicular to the skin, because at this distance the projected image corresponds to the actual size of the veins located below the skin. It will be either attached to an articulated arm in order to free the operator's hands to perform the procedure, or held by an assistant above the venipuncture site. The assistant can reorient the device during the procedure. The light from the AccuVein® device should not be aimed at the child's eyes. In neonatal intensive care and neonatology, during any use, the newborn's eyes will be covered during the procedure's implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Venipuncture without near-infrared light | |
| Experimental group | Experimental | Venipuncture with near-infrared light |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venipuncture with near-infrared light | Procedure | with near-infrared light to locate the veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| First venipuncture attempt | Obtention 0.5 ml of blood injection of 1.5 ml of physiological serum without extravasation after the first blood sampling attempt or the first attempt of a peripheral venous line. | at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful venepuncture duration | Duration from application of tourniquet to obtention of 0.5 ml of blood After the first blood sampling attempt or the first attempt of a peripheral venous line at most after the 3rd venepuncture attempt | at day 0 |
| Pain evaluation during venipuncture |
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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 or for insertion of a peripheral venous line 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 or for insertion of a peripheral venous line 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
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo CARBAJAL, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Trousseau | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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 |
| 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 |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |