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Not yet recruitingNCT07315711Updated Jan 2, 2026

The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients

An observational study in Peripheral Vascular Access in Pediatric Patients, Peptic Ulcer and Cataract, sponsored by Sibel Seçkin Pehlivan. Not yet recruiting at 6 sites in Turkey (Türkiye). Open to participants aged 0 Days to 18 Days. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Sibel Seçkin Pehlivan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
0 Days to 18 Days
Sex
All
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Study 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.

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Conditions studied

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

Keywords

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

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's planned enrollment of 500 is above the median of 391 across 43 observational studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

This is the only study on the registry with Sibel Seçkin Pehlivan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Days to 18 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-intervention/procedure/surgery

  2. 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.

    Time frame: pre-intervention/procedure/surgery

Secondary outcomes

  1. number of interventions (each new skin entry of the needle)

    The number of interventions refers to the total count of new skin entries made with the needle during peripheral vascular access attempts. Each distinct insertion of the needle through the skin, regardless of whether it occurs during the same cannulation effort or a subsequent repositioning, is recorded as a separate intervention. This metric will be used to assess procedural invasiveness and will be compared between patients who undergo vascular access with versus without vascular imaging device assistance

    Time frame: pre-intervention/procedure/surgery

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Study locations

6 sites
  • Erciyes University Hospital
    Kayseri, Kayseri̇ 38039, Turkey (Türkiye)
  • Erciyes University Hospital
    Kayseri, 38039, Turkey (Türkiye)
  • Erciyes University Hospital
    Kayseri, 38039, Turkey (Türkiye)
  • Erciyes University Hospital
    Kayseri, 38039, Turkey (Türkiye)
  • Erciyes University Hospital
    Kayseri, 38039, Turkey (Türkiye)
  • Erciyes University Hospital
    Kayseri, 38039, Turkey (Türkiye)
    • Sibel seckin Pehlivan, Assistant Professor · Contact · sibelpehlivan@erciyes.edu.tr · 09005052532919
    • Recep Aksu, professor · Contact · raksu@erciyes.edu.tr · 09005337461200
    • Sibel Seckin Pehlivan, Assistant Professor · Principal investigator
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Data are stored securely in accordance with local regulations, and dissemination is limited to aggregated results to protect the privacy of pediatric patients involved in the study.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07315711
Lead sponsor
Sibel Seçkin Pehlivan
Responsible party
Sibel Seçkin Pehlivan (Assistant Professor, TC Erciyes University) — Sponsor-investigator
First posted
Jan 2, 2026
Start date
Dec 1, 2025 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jan 2, 2026

Study contacts

Sibel Seckin Pehlivan, Assistant Professor
Contact
sibelpehlivan@erciyes.edu.tr
0905052532919
RECEP AKSU, PROFESSOR
Contact
sibelpehlivan@erciyes.edu.tr
0905337461200
Sibel Seckin Pehlivan
principal investigator · Department of Anaesthesiology and Reanimation, Erciyes University, Kayseri, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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