The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorSibel Seçkin Pehlivan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
Disqualifiers
None
Trial population
Pediatric patients aged 0-18 years scheduled for day-case surgery or non-operating room anesthesia (NORA)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Intervention Group
Group B: Control Group
Trial outcomes
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/surgery2
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/surgerySecondary 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/surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sibel Seçkin Pehlivan
Lead sponsor
TC Erciyes University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: