Peripheral Intravenous CatheterNCT06233214
The Effect of the Vein Imaging Device Used in Peripheral Intravenous Catheter Application on the Success of the Procedure in Patients Coming to the Pediatric Emergency Department
A study testing vein imaging device in people with Peripheral Intravenous Catheter, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral Intravenous Catheter (PIC) application in pediatric wards of hospitals; It is used in the administration of drugs that require diarrhea, vomiting, dehydration or high serum concentration, resistant infections, parenteral treatments, continuous bolus analgesic needs and emergency treatment situations. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Intravenous Catheter
- What is being tested?
- vein imaging device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between the ages of 6-12,
- The child is receiving treatment through peripheral vascular access,
- Parent and child agree to participate in the research,
- PIK placement is done by the same nurse,
- PIK placement should be performed with the same catheter number (24-G or 22-G) and brand.
Who cannot join
- Children falling outside the inclusion criteria will be included in the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Manisa Hafsa Sultan Hospital
Manisa
Duygu Karaarslan
About this study
Peripheral Intravenous Catheter (PIC) application in pediatric wards of hospitals; It is used in the administration of drugs that require diarrhea, vomiting, dehydration or high serum concentration, resistant infections, parenteral treatments, continuous bolus analgesic needs and emergency treatment situations. Although PIC is a frequently used practice, especially in pediatric emergency departments, it is seen as a difficult approach for healthcare professionals. PIC applications may be more difficult in pediatric patients due to their small vascular structures, the fact that the vessels are surrounded by subcutaneous tissue, and lack of communication. Every child's venous anatomy is different. Therefore, selecting the appropriate vein by ensuring palpation and using appropriate tools before the procedure will reduce the pain and stress the child will experience. Biomedical tools are used to increase success in vascular interventions. Studies have shown that PIC procedure time is shorter in pediatric patients using vein imaging devices and the number of interventions is lower than the control group.
Read the detailed description
Assistive devices may be needed to perform this procedure, which is quite painful and anxiety-inducing for children, all at once and in a short time. In this regard, there is no device support for PIC application for pediatric patients at Manisa Celal Bayar University Hafsa Sultan Hospital. The investigators predict that by introducing the vein imaging device to the Pediatric Emergency Department of our hospital, the success rate of PIC application will increase and the number of interventions will decrease by enabling the vein to be visualized and selected in pediatric patients. Due to these processes experienced by pediatric patients, the aim of our research is to examine the effect of the vein imaging device used during peripheral intravenous catheter application on the success of the procedure in pediatric patients. Method: The population of the research will consist of pediatric patients between the ages of 6-12 who applied to the Pediatric Emergency Department of Manisa Celal Bayar University, Hafsa Sultan Hospital. The adequacy of the sample size in the study "G. Calculated using the "Power-3.1.9.2" program. In the power analysis performed for the sample and power calculation of the experimental study, 30 pediatric patients were determined for each group at the p = 0.05 level, 80% representative power of the population and 95% confidence interval. However, considering the missing data, it was planned to conduct a study with 35 children for the experimental and control groups. Randomization was performed using the random numbers table obtained from the computer program (https://www.randomizer.org/).
Research data will be collected at Manisa Celal Bayar University Hafsa Sultan Hospital Pediatric Emergency Service. The research was planned as an experimental (n: 35) and control (n: 35) group.
In collecting data;
- Informed Volunteer Consent Form (Appendix I).
- Interview and Observation Form (Annex II).
- Challenging Intravenous Intervention Score for Children (Appendix III).
- ACCUVEIN AV 500 vein imaging device (Annex IV)
- Peripheral cannula (Yellow color No. 24 G or Blue color No. 22 G) (Annex V): will be used.
Data collection phase; Pediatric patients and their families who come to the pediatric emergency department will be informed about the vein imaging device to be used in the research and how the research will be conducted. Their consent will be taken. PIK placement attempt will be performed with the help of a vein imaging device in the experimental group, and with the traditional application method without device support in the control group. PIC placement in both groups will be performed by a specialist nurse working in the pediatric emergency department, who has 5 years of experience in caring for pediatric patients and performing IV interventions. In order to avoid differences in practice, the procedure for establishing peripheral vascular access for all children will be provided by the same nurse. In both groups, all PIK procedures will be performed with the same catheter number (24-G yellow or 22-G blue) and the same brand catheter (Braun) to avoid differences. Another pediatric emergency nurse who has been working in the pediatric emergency department for at least 2 years, independent of the research, will also act as an observer. When evaluating the duration of the PIK placement attempt; Before the child's vein is searched, the stopwatch will be turned on as soon as the tourniquet is tied and the time will be stopped when the patency of the vascular access is ensured (from the time the tourniquet is tied until the physiological saline is given). If the vascular access fails in the first attempt, a new vein will be searched and time will be kept until the procedure is successful. Once vascular access is established, the time will be stopped and the procedure time will be recorded. The observing nurse will evaluate the "Interview and Observation Form" and the "Difficult Intravenous Intervention Score for Children".
- Conditions
- Peripheral Intravenous Catheter
- Being tested
- vein imaging device
- Keywords
- pediatrics, peripheral intravenous catheter application, vein imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vein imaging deviceDevice
During the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure.
PIC placement attempt will be performed on the experimental group with the help of a vein imaging device.
| Study group | Role | What they receive |
|---|---|---|
| vein imaging device | Experimental | During the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure.
PIC placement attempt will be performed on the experimental group with the help of a vein imaging device. Receives: Device: vein imaging device |
| control group | No intervention | PIC placement attempt will be performed in the control group using the traditional application method without device support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview and Observation Form
This form consists of 13 items developed based on the available literature. The first five items question demographic characteristics, and the others question the success of the procedure regarding the number of attempts and their duration.
Measured: it will take approximately 5 minutes to fill out the form.
Secondary outcomes (1)
Difficult Intravenous Access Score
It was developed by Yen et al. The DIVA score with 4 parameters (visibility, palpability, age, and prematurity history) was found to be valid and reliable for Turkish children. The vascular access is assessed as difficult with a 50% failure rate if the total score is 4 and above.
Measured: it will take approximately 1 minutes to fill out the form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous CatheterStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PIC placement attempt will be performed with the help of a vein imaging device in the study/experiment group, and with the traditional application method without device support in the control group.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duygu Karaarslan, Study director, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233214
- Sponsor's protocol ID
- vein imaging
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Vein Imaging Device Used in Peripheral Intravenous Catheter Application on the Success of the Procedure in Patients Coming to the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT06233214
- Acronym / sponsor ID
- vein imaging
- Conditions
- Peripheral Intravenous Catheter
- Keywords
- pediatrics, peripheral intravenous catheter application, vein imaging device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
Peripheral Intravenous Catheter (PIC) application in pediatric wards of hospitals; It is used in the administration of drugs that require diarrhea, vomiting, dehydration or high serum concentration, resistant infections, parenteral treatments, continuous bolus analgesic needs and emergency treatment situations. Although PIC is a frequently used practice, especially in pediatric emergency departments, it is seen as a difficult approach for healthcare professionals. PIC applications may be more difficult in pediatric patients due to their small vascular structures, the fact that the vessels are surrounded by subcutaneous tissue, and lack of communication. Every child's venous anatomy is different. Therefore, selecting the appropriate vein by ensuring palpation and using appropriate tools before the procedure will reduce the pain and stress the child will experience. Biomedical tools are used to increase success in vascular interventions. Studies have shown that PIC procedure time is shorter in pediatric patients using vein imaging devices and the number of interventions is lower than the control group.
Detailed description
Assistive devices may be needed to perform this procedure, which is quite painful and anxiety-inducing for children, all at once and in a short time. In this regard, there is no device support for PIC application for pediatric patients at Manisa Celal Bayar University Hafsa Sultan Hospital. The investigators predict that by introducing the vein imaging device to the Pediatric Emergency Department of our hospital, the success rate of PIC application will increase and the number of interventions will decrease by enabling the vein to be visualized and selected in pediatric patients. Due to these processes experienced by pediatric patients, the aim of our research is to examine the effect of the vein imaging device used during peripheral intravenous catheter application on the success of the procedure in pediatric patients. Method: The population of the research will consist of pediatric patients between the ages of 6-12 who applied to the Pediatric Emergency Department of Manisa Celal Bayar University, Hafsa Sultan Hospital. The adequacy of the sample size in the study "G. Calculated using the "Power-3.1.9.2" program. In the power analysis performed for the sample and power calculation of the experimental study, 30 pediatric patients were determined for each group at the p = 0.05 level, 80% representative power of the population and 95% confidence interval. However, considering the missing data, it was planned to conduct a study with 35 children for the experimental and control groups. Randomization was performed using the random numbers table obtained from the computer program (https://www.randomizer.org/).
Research data will be collected at Manisa Celal Bayar University Hafsa Sultan Hospital Pediatric Emergency Service. The research was planned as an experimental (n: 35) and control (n: 35) group.
In collecting data;
- Informed Volunteer Consent Form (Appendix I).
- Interview and Observation Form (Annex II).
- Challenging Intravenous Intervention Score for Children (Appendix III).
- ACCUVEIN AV 500 vein imaging device (Annex IV)
- Peripheral cannula (Yellow color No. 24 G or Blue color No. 22 G) (Annex V): will be used.
Data collection phase; Pediatric patients and their families who come to the pediatric emergency department will be informed about the vein imaging device to be used in the research and how the research will be conducted. Their consent will be taken. PIK placement attempt will be performed with the help of a vein imaging device in the experimental group, and with the traditional application method without device support in the control group. PIC placement in both groups will be performed by a specialist nurse working in the pediatric emergency department, who has 5 years of experience in caring for pediatric patients and performing IV interventions. In order to avoid differences in practice, the procedure for establishing peripheral vascular access for all children will be provided by the same nurse. In both groups, all PIK procedures will be performed with the same catheter number (24-G yellow or 22-G blue) and the same brand catheter (Braun) to avoid differences. Another pediatric emergency nurse who has been working in the pediatric emergency department for at least 2 years, independent of the research, will also act as an observer. When evaluating the duration of the PIK placement attempt; Before the child's vein is searched, the stopwatch will be turned on as soon as the tourniquet is tied and the time will be stopped when the patency of the vascular access is ensured (from the time the tourniquet is tied until the physiological saline is given). If the vascular access fails in the first attempt, a new vein will be searched and time will be kept until the procedure is successful. Once vascular access is established, the time will be stopped and the procedure time will be recorded. The observing nurse will evaluate the "Interview and Observation Form" and the "Difficult Intravenous Intervention Score for Children".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- PIC placement attempt will be performed with the help of a vein imaging device in the study/experiment group, and with the traditional application method without device support in the control group.
| Arm | Type | Receives |
|---|---|---|
| vein imaging device | Experimental | Device: vein imaging deviceDuring the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure. PIC placement attempt will be performed on the experimental group with the help of a vein imaging device. |
| control group | No intervention | –PIC placement attempt will be performed in the control group using the traditional application method without device support. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is between the ages of 6-12,
- The child is receiving treatment through peripheral vascular access,
- Parent and child agree to participate in the research,
- PIK placement is done by the same nurse,
- PIK placement should be performed with the same catheter number (24-G or 22-G) and brand.
Key exclusion criteria (1 listed)
- Children falling outside the inclusion criteria will be included in the exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vein imaging deviceDuring the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure. PIC placement attempt will be performed on the experimental group with the help of a vein imaging device. | Device | vein imaging device |
Primary outcome
Interview and Observation Form
Time frame: it will take approximately 5 minutes to fill out the form.
This form consists of 13 items developed based on the available literature. The first five items question demographic characteristics, and the others question the success of the procedure regarding the number of attempts and their duration.
1 secondary outcome
Difficult Intravenous Access Score
Time frame: it will take approximately 1 minutes to fill out the form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Duygu Karaarslan study director
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vein imaging device in people with Peripheral Intravenous Catheter, run by Manisa Celal Bayar University at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Karaarslan (5062146960, duygukrrsln@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview and Observation Form (time frame: it will take approximately 5 minutes to fill out the form.). 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 31 Jan 2024.