Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT05831605
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALPIVEINE
Brief Summary:
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.
Detailed Description:
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:
* Takes the next consecutively numbered randomization envelope from the room intended for this purpose. This envelope is opaque and contains the randomization group in which the child is assigned (near infrared light or standard technique)
* Takes a study observation book located in the room intended for this purpose.
* Once the nurse is ready to do the venipuncture and before having identified the vein to be punctured, he/she opens the envelope to find out whether or not near infrared light will be used for spotting the vein to be punctured while the person (caregiver or nurse) who will help him during the procedure is present.
* Venous blood sampling or insertion of a venous line according to the technique indicated by the randomization (near infrared light or standard technique) for the first attempt at venipuncture.
* If the first venipuncture attempt fails, the nurse can chose to carry out the 2nd or 3rd attempt with or without near infrared light. Only the first 3 attempts progress will be recorded in the observation book.
* When the venous blood drawing or the insertion of a venous line is over, whether it is successful or not, the assistant present during the procedure completes the observation book on the sampling part.
* The notebook and the envelope used are stored in the room intended for this purpose.
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.
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:
* Takes the next consecutively numbered randomization envelope from the room intended for this purpose. This envelope is opaque and contains the randomization group in which the child is assigned (near infrared light or standard technique)
* Takes a study observation book located in the room intended for this purpose.
* Once the nurse is ready to do the venipuncture and before having identified the vein to be punctured, he/she opens the envelope to find out whether or not near infrared light will be used for spotting the vein to be punctured while the person (caregiver or nurse) who will help him during the procedure is present.
* Venous blood sampling or insertion of a venous line according to the technique indicated by the randomization (near infrared light or standard technique) for the first attempt at venipuncture.
* If the first venipuncture attempt fails, the nurse can chose to carry out the 2nd or 3rd attempt with or without near infrared light. Only the first 3 attempts progress will be recorded in the observation book.
* When the venous blood drawing or the insertion of a venous line is over, whether it is successful or not, the assistant present during the procedure completes the observation book on the sampling part.
* The notebook and the envelope used are stored in the room intended for this purpose.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID-RCB | REGISTRY | 2022-A02584-39 | View |