Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light (ALPIVEINE)

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.

Study Overview

• Status: Recruiting
• Conditions: Venipuncture
• Intervention / Treatment: Procedure: venipuncture with near-infrared light

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 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. 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, 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 collection is present.
• Venous blood sampling 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 is over, whether it is successful or not, the assistant present during the sampling 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 Type: Interventional
• Enrollment (Estimated): 452
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nelly BRIAND, PhD; Phone Number: +33 1 44 38 18 62; Email: nelly.briand@aphp.fr
• Study Contact Backup: Name: Delphine DUCOURNAU, Nurse; Phone Number: +33 1.71.73.88.85; Email: delphine.ducournau@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Hôpital Trousseau
    • Contact: Delphine DUCOURNAU, Nurse; Phone Number: +33 1.71.73.88.85; Email: delphine.ducournau@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Venipuncture without near-infrared light
Experimental: Experimental group; Venipuncture with near-infrared light	Procedure: venipuncture with near-infrared light; with near-infrared light to locate the veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with first venipuncture attempt	Obtention 0.5 ml of blood	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Ricardo CARBAJAL, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Venipuncture; Near Infrared Light; Paediatric venepuncture; Venous blood sampling
• Other Study ID Numbers: D20170121; ID-RCB (Other Identifier: 2023-A01937-38)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No