Trial Outcomes & Findings for A Comparison of Accuvein to Standard IV Access in Children 0 to 24 Months of Age in the Pediatric ED (NCT NCT02381392)
NCT ID: NCT02381392
Last Updated: 2018-04-23
Results Overview
Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
AV400
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AV400
n=11 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=12 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
23 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
8 Participants
n=12 Participants
|
16 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
12 participants
n=12 Participants
|
23 participants
n=23 Participants
|
|
Fitzpatrick skin color
I
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=23 Participants
|
|
Fitzpatrick skin color
II
|
4 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=23 Participants
|
|
Fitzpatrick skin color
III
|
5 Participants
n=11 Participants
|
8 Participants
n=12 Participants
|
13 Participants
n=23 Participants
|
|
Fitzpatrick skin color
IV
|
1 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=23 Participants
|
|
Fitzpatrick skin color
V
|
1 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=23 Participants
|
|
Dehydration status
None
|
2 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
6 Participants
n=23 Participants
|
|
Dehydration status
Mild
|
9 Participants
n=11 Participants
|
5 Participants
n=12 Participants
|
14 Participants
n=23 Participants
|
|
Dehydration status
Moderate
|
0 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=23 Participants
|
|
Dehydration status
Missing data
|
0 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=23 Participants
|
|
Mental status
Combative
|
7 Participants
n=11 Participants
|
8 Participants
n=12 Participants
|
15 Participants
n=23 Participants
|
|
Mental status
Cooperative
|
3 Participants
n=11 Participants
|
3 Participants
n=12 Participants
|
6 Participants
n=23 Participants
|
|
Mental status
Missing data
|
1 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Intravenous access attempts during the current emergency department visit only, average of 60 minutesSuccessful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.
Outcome measures
| Measure |
AV400
n=11 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=12 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
First Attempt Success at Intravenous Access
Successful
|
3 Participants
|
7 Participants
|
|
First Attempt Success at Intravenous Access
Flashback but IV blown
|
5 Participants
|
3 Participants
|
|
First Attempt Success at Intravenous Access
No flashback
|
2 Participants
|
2 Participants
|
|
First Attempt Success at Intravenous Access
Missing data
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intravenous access attempts during the current emergency department visit only, average of 60 minutesTo compare the median number of IV access attempts until success or escalation of therapy to the difficult IV access team between those placed with the AV400 as to those without (ie the standard technique).
Outcome measures
| Measure |
AV400
n=11 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=12 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
Median Number of Intravenous Attempts
1
|
3 Participants
|
7 Participants
|
|
Median Number of Intravenous Attempts
2
|
4 Participants
|
3 Participants
|
|
Median Number of Intravenous Attempts
3
|
1 Participants
|
2 Participants
|
|
Median Number of Intravenous Attempts
5 or more
|
2 Participants
|
0 Participants
|
|
Median Number of Intravenous Attempts
Missing data
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intravenous access attempts during the current emergency department visit only, average of 60 minutesTo compare parent satisfaction using a Likert scale between use of the AV400 and the standard technique
Outcome measures
| Measure |
AV400
n=11 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=12 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
Parent Satisfaction (Likert Scale)
Very satisfied
|
0 Participants
|
2 Participants
|
|
Parent Satisfaction (Likert Scale)
Extremely satisfied
|
0 Participants
|
3 Participants
|
|
Parent Satisfaction (Likert Scale)
Satisfied
|
2 Participants
|
2 Participants
|
|
Parent Satisfaction (Likert Scale)
Partially satisfied
|
6 Participants
|
3 Participants
|
|
Parent Satisfaction (Likert Scale)
Dissatisfied
|
1 Participants
|
0 Participants
|
|
Parent Satisfaction (Likert Scale)
Missing data
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Intravenous access attempts during the current emergency department visit only, average of 60 minutesTo compare nursing satisfaction using a Likert scale between use of the AV400 and the standard technique.
Outcome measures
| Measure |
AV400
n=11 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=12 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
Nursing Satisfaction (Likert Scale)
Extremely satisfied
|
0 Participants
|
1 Participants
|
|
Nursing Satisfaction (Likert Scale)
Very satisfied
|
3 Participants
|
1 Participants
|
|
Nursing Satisfaction (Likert Scale)
Satisfied
|
2 Participants
|
5 Participants
|
|
Nursing Satisfaction (Likert Scale)
Partially satisfied
|
3 Participants
|
1 Participants
|
|
Nursing Satisfaction (Likert Scale)
Dissatisfied
|
1 Participants
|
2 Participants
|
|
Nursing Satisfaction (Likert Scale)
Missing data
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Intravenous access attempts during the current emergency department visit only, average of 60 minutesSuccessful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.
Outcome measures
| Measure |
AV400
n=4 Participants
The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.
Accuvein AV400: This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
|
Standard
n=5 Participants
The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.
|
|---|---|---|
|
Success in Patients With High Difficult Intravenous Access Scores
Flashback but IV blown
|
1 Participants
|
0 Participants
|
|
Success in Patients With High Difficult Intravenous Access Scores
Successful
|
2 Participants
|
4 Participants
|
|
Success in Patients With High Difficult Intravenous Access Scores
No flashback
|
1 Participants
|
1 Participants
|
Adverse Events
AV400
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place