Dokuz Eylul University
Izmir, 35100, Turkey (Türkiye)
NCT Number: NCT07006038
This study aimed to evaluate the impact of vein visualization device on catheter placement success and catheter-related complications during peripheral IV catheter insertion in pediatric emergency departments. This randomized controlled trial compares the group using a vein visualization device with the group using the standard method.
Looking for future studies?
Notify Me1 month–6 year
All sexes
Interventional
Not applicable
Izmir, 35100, Turkey (Türkiye)
There were two groups in this study: the vein imaging device and the control group.
The children to be included in this study consisted of pediatric patients who were admitted to the PED. There were two groups in this study: the vein imaging device and the control group. If the physician requested a peripheral intravenous catheter (PIC), the vein imaging device was applied to increase the first-attempt success of the PIC in one group. In addition, there was a control group in which any device was not used. One trained nurse who was a PhD student enrolled the participants who met the eligibility criteria.
The patients who were scheduled for PIC insertion were allocated to groups according to the randomization scheme. After providing information to the child and the parent, the investigator obtained consent from the parent, and the group assignment was determined. The patients in the control group did not receive any additional interventions and were observed during the PIC insertion after obtaining consent.
The PIC procedure time started when the tourniquet connected. In the vein imaging device and the control groups, communication with the child was maintained using the questions mentioned above during the procedure by the researcher nurse. When the phlebotomist nurse decided on the insertion site for the PIC, the PIC was attempted. If the PIC was inserted on the first attempt, the PIC procedure time stopped. If not, when the PIC was successfully inserted, the PIC procedure time was stopped. The PIC insertion time was recorded in minutes for successful PIC insertion. After the PIC insertion area was closed with dressing and the materials were collected, the child's pain was assessed by the PED nurse with the FLACC pain scale.
Complication signs and symptoms are monitored in the PIC area. If the PIC is to be removed for any reason, the reason and time of removal are recorded. PIC indwelling time was recorded. If it was removed due to a complication, the PIC area was followed up by grading with infiltration, extravasation, and phlebitis scales.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Veinlite PEDI2 used before the catheter insertion.
Time frame: through the PIC insertion
first-attempt PIC insertion success
Time frame: through the PIC insertion
procedural time for successful PIC insertion
Time frame: FLACC score evaluated 3 minutes after the PIC insertion
The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIC insertion. The scale is scored in a range of 0-10, with 0 representing no pain. Assessment of score:
0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time frame: through the PIC stay (If the PIC is to be removed for any reason, the reason and time of removal are recorded, PIC indwelling time was recorded as hours)
PIC stay time
Dokuz Eylul University
Other
Vein Imaging Device on First-Attempt Success and Catheter Complications in Peripheral Intravenous Catheter Insertion
Acronym: Veinimaging
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03502655
Acute Pain, Behavior
Lausanne, Canton of Vaud, Switzerland
View Trial DetailsNCT06851585
Catheterization, Catheterization, Peripheral
Poitiers, France
View Trial DetailsNCT04499638
Cardiovascular Diseases, Catheter-Related Infections
Barcelona, Spain
View Trial DetailsNCT06562829
Catheterization, Peripheral
Wuhan, Hubei, China
View Trial Details