Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance

NCT ID: NCT06465121

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-05-31

Brief Summary

Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone.

For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.

Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).

Detailed Description

Venipunctures are very common in hospitalized patients. Obtaining venous access is more difficult in the pediatric population, particularly due to the smaller size of the vessels and the more difficult cooperation of patients. Traditional method for inserting intravenous catheter access requires knowledge of vascular anatomy to estimate the location of the target vein and requires visualization or palpation of the vein. The success rate for peripheral intravenous catheterization in pediatric patients is approximately 60% after one attempt and 90% after four. Delays in intravenous access can result in significant morbidity and mortality. Thus, alternative methods should be considered to improve pediatric access sites.

Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access. This could also have an impact on the frequency of the main associated adverse events.

For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.

Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).

Children will be followed for a maximum of 7 days or until discharge from hospitalization.

Conditions

Catheter Related Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound guidance

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Group Type: EXPERIMENTAL

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Intervention Type: PROCEDURE

Intravenous catheterization using ultrasound-guidance to allow real-time visualization of target veins in pediatric patients with difficult intravenous access

Standard of care

Peripheral intravenous catheterization by visualization and palpation of the vein alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Intravenous catheterization using ultrasound-guidance to allow real-time visualization of target veins in pediatric patients with difficult intravenous access

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age ≥ 1 month and < 18 years
• intravenous catheter insertion indicated for hospital care
• DIVA (Difficult Intravenous Access Scale) score ≥ 4
• hospitalized in one of the pediatric departments of the Reims University Hospital
• who agree to participate in the study (if old enough to understand) and for whom the consent of the holder(s) of parental authority has been obtained
• affiliated to a social security scheme

Exclusion Criteria

• Newborns (< 1 month) and premature babies hospitalized in neonatal intensive care, neonatology and maternity units
• Known vascular pathology
• Hemodialysis with arteriovenous fistula
• Unstable hemodynamic and/or respiratory clinical state according to the judgment of the medical team

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Countries

France

Central Contacts

Cindy COLLET

Role: CONTACT

cindycollet88@gmail.com

0326787878 ext. 0033

Caroline WOLFERT-CATTANEO

Role: CONTACT

carowolf@orange.fr

0326787878 ext. 0033

Facility Contacts

Damien JOLLY, Pr.

Role: primary

djolly@chu-reims.fr

326788472 ext. 33

Other Identifiers

PP24044*

Identifier Type: -

Identifier Source: org_study_id