Peripheral Vascular Access in Pediatric PatientsNCT07315711
The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients
An observational study of Peripheral Vascular Access in Pediatric Patients and Peptic Ulcer, run by Sibel Seçkin Pehlivan at 6 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 days
- Conditions the study is for
- Peripheral Vascular Access in Pediatric Patients, Peptic Ulcer, Cataract
- How many people
- 500 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 days
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Turkey (Türkiye)6 sites
Erciyes University Hospital
Kayseri, Kayseri̇, 38039
Erciyes University Hospital
Kayseri, 38039
Sibel seckin Pehlivan, md, sibelpehlivan@erciyes.edu.tr
Sibel Seckin Pehlivan, sibelpehlivan@erciyes.edu.tr
Erciyes University Hospital
Kayseri, 38039
Sibel Pehlivan, sibelpehlivan@erciyes.edu.tr
Erciyes University Hospital
Kayseri, 38039
Sibel seckin Pehlivan, Assistant Professor, 09005052532919, sibelpehlivan@erciyes.edu.tr
Sibel Seckin Pehlivan, Assistant Professor, 0905052532919, sibelpehlivan@erciyes.edu.tr
Erciyes University Hospital
Kayseri, 38039
Erciyes University Hospital
Kayseri, 38039
Sibel seckin Pehlivan, Assistant Professor, 09005052532919, sibelpehlivan@erciyes.edu.tr
Recep Aksu, professor, 09005337461200, raksu@erciyes.edu.tr
About this study
Official title: The Effect of Vascular Imaging Devices on the Success Rate of Peripheral Vascular Access in Pediatric Patients Undergoing Day-Case and Non-Operating Room Anesthesia Procedures
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.
- Keywords
- non-operating room anesthesia (NORA), peripheral vascular access, pediatric patienent
- Medical subject headings
- Peptic Ulcer, Cataract, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: pre-intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular Access in Pediatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sibel Seçkin Pehlivan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Seckin Pehlivan, Principal investigator, Department of Anaesthesiology and Reanimation, Erciyes University, Kayseri, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315711
- Sponsor's protocol ID
- 2025/454
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vascular Imaging Devices on the Success Rate of Peripheral Vascular Access in Pediatric Patients Undergoing Day-Case and Non-Operating Room Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT07315711
- Acronym / sponsor ID
- 2025/454
- Keywords
- non-operating room anesthesia (NORA), peripheral vascular access, pediatric patienent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sibel Seçkin PehlivanUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 18 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The time to establish peripheral vascular access
Time frame: pre-intervention/procedure/surgery
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.
number of attempts
Time frame: pre-intervention/procedure/surgery
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.
1 secondary outcome
number of interventions (each new skin entry of the needle)
Time frame: pre-intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sibel Seckin Pehlivan principal investigator
Department of Anaesthesiology and Reanimation, Erciyes University, Kayseri, Turkey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Access in Pediatric Patients and Peptic Ulcer, run by Sibel Seçkin Pehlivan at 6 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibel Seckin Pehlivan, Assistant Professor (0905052532919, sibelpehlivan@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to establish peripheral vascular access (time frame: pre-intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.