Brief Summary

The study was designed as a prospective, observational study. Pediatric patients under 18 years of age scheduled for peripheral vascular access placement during day-case surgery or non-operating room anesthesia (NORA) will be included. The primary outcomes include time to successful vascular access, number of attempts, and number of interventions (defined as each new skin entry of the needle). These outcomes will be compared between two groups: those who receive vascular access with the aid of a vascular imaging device and those in whom such a device is not used.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Dec 2025

Geographic Reach

1 country

6 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Progress22%

Dec 2025Dec 2027

Study Start

First participant enrolled

December 1, 2025

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed

23 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 10, 2025

Last Update Submit

December 23, 2025

Conditions

Peripheral Vascular Access in Pediatric Patients Peptic Ulcer Cataract Crohn's Disease

Keywords

non-operating room anesthesia (NORA), peripheral vascular access, pediatric patienent

Outcome Measures

Primary Outcomes (2)

The time to establish peripheral vascular access
The primary outcome measure is the time required to successfully establish peripheral vascular access, defined as the interval from the first needle insertion attempt to the confirmation of intravenous placement (e.g., blood return and/or free flow of saline). This metric will be recorded in seconds and compared between patients who receive vascular imaging assistance and those who do not.
pre-intervention/procedure/surgery
number of attempts
The number of attempts refers to the total number of needle insertions required to achieve successful peripheral vascular access, with each attempt defined as a distinct skin puncture. An attempt is counted even if cannulation is not achieved. This outcome will be documented for each patient and compared between the group using vascular imaging devices and the group without such assistance.
pre-intervention/procedure/surgery

Secondary Outcomes (1)

number of interventions (each new skin entry of the needle)
pre-intervention/procedure/surgery

Study Arms (2)

Intervention Group

Pediatric patients undergoing peripheral vascular access with the use of a vascular imaging device. The intervention involves the application of real-time imaging guidance (e.g., near-infrared light or ultrasound) to facilitate successful and efficient cannulation.

Control Group

Pediatric patients undergoing peripheral vascular access without the use of a vascular imaging device, relying on standard visual and palpation techniques.

Eligibility Criteria

Age0 Days - 18 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodProbability Sample

Study Population

Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)

You may qualify if:

Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
Patients requiring peripheral vascular access (those with a need for intravenous access)
Patients whose parent or legal guardian can provide written informed consent
Patients suitable for vascular access using a vascular imaging device

You may not qualify if:

Patients requiring emergency surgery or urgent intervention
Patients whose parent or legal guardian cannot provide informed consent
Patients with local extremity problems such as infection, edema, or wound that prevent peripheral vascular access placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sibel Seçkin Pehlivanlead

Study Sites (6)

Erciyes University Hospital

Kayseri, Kayseri̇, 38039, Turkey (Türkiye)

Location

Erciyes University Hospital