Trial Outcomes & Findings for Infra Red Vein Visualization: Efficacy vs. Standard Technique (NCT NCT03181542)
NCT ID: NCT03181542
Last Updated: 2021-12-21
Results Overview
Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes
Results posted on
2021-12-21
Participant Flow
Potential subjects will be identified from the electronic operating room scheduling system (surginet) by reviewing the operative list schedule the day before or on the day of their scheduled surgical or diagnostic procedure.
Participant milestones
| Measure |
Infrared Vein Illumination
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
Standard vein location techniques will be used when inserting an intravenous access line
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Infrared Vein Illumination
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
Standard vein location techniques will be used when inserting an intravenous access line
|
|---|---|---|
|
Overall Study
Subject withdrawn because research physician could not make it in time to place IV
|
1
|
0
|
Baseline Characteristics
Skin color data was not collected from 1 standard subject
Baseline characteristics by cohort
| Measure |
Infrared Vein Illumination
n=79 Participants
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
n=80 Participants
Standard vein location techniques will be used when inserting an intravenous access line
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.11 months
STANDARD_DEVIATION 6.19 • n=79 Participants
|
12.42 months
STANDARD_DEVIATION 6.44 • n=80 Participants
|
12.76 months
STANDARD_DEVIATION 6.31 • n=159 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=79 Participants
|
38 Participants
n=80 Participants
|
74 Participants
n=159 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=79 Participants
|
42 Participants
n=80 Participants
|
85 Participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
60 participants
n=79 Participants
|
56 participants
n=80 Participants
|
116 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=79 Participants
|
8 participants
n=80 Participants
|
13 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
8 participants
n=79 Participants
|
10 participants
n=80 Participants
|
18 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=79 Participants
|
2 participants
n=80 Participants
|
4 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
3 participants
n=79 Participants
|
2 participants
n=80 Participants
|
5 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=79 Participants
|
1 participants
n=80 Participants
|
2 participants
n=159 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=79 Participants
|
1 participants
n=80 Participants
|
1 participants
n=159 Participants
|
|
Region of Enrollment
United States
|
79 Participants
n=79 Participants
|
80 Participants
n=80 Participants
|
159 Participants
n=159 Participants
|
|
Skin Color
Light
|
60 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
57 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
117 Participants
n=158 Participants • Skin color data was not collected from 1 standard subject
|
|
Skin Color
Medium
|
15 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
18 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
33 Participants
n=158 Participants • Skin color data was not collected from 1 standard subject
|
|
Skin Color
Dark
|
4 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
4 Participants
n=79 Participants • Skin color data was not collected from 1 standard subject
|
8 Participants
n=158 Participants • Skin color data was not collected from 1 standard subject
|
|
Anticipated IV access difficulty
0
|
0 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
5 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
5 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Anticipated IV access difficulty
1
|
14 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
9 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
23 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Anticipated IV access difficulty
2
|
22 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
19 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
41 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Anticipated IV access difficulty
3
|
23 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
26 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
49 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Anticipated IV access difficulty
4
|
11 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
11 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
22 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Anticipated IV access difficulty
5
|
9 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
9 participants
n=79 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
18 participants
n=158 Participants • Data was not collected for the anticipated IV access difficulty for 1 standard subject
|
|
Prematurity
yes
|
13 Participants
n=78 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
12 Participants
n=80 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
25 Participants
n=158 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
|
Prematurity
no
|
65 Participants
n=78 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
68 Participants
n=80 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
133 Participants
n=158 Participants • Prematurity data was not entered for 1 Infrared vein illumination subject
|
|
ASA physical Status
1
|
19 Participants
n=79 Participants
|
21 Participants
n=80 Participants
|
40 Participants
n=159 Participants
|
|
ASA physical Status
2
|
47 Participants
n=79 Participants
|
43 Participants
n=80 Participants
|
90 Participants
n=159 Participants
|
|
ASA physical Status
3
|
13 Participants
n=79 Participants
|
16 Participants
n=80 Participants
|
29 Participants
n=159 Participants
|
|
ASA physical Status
4
|
0 Participants
n=79 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=159 Participants
|
|
ASA physical Status
5
|
0 Participants
n=79 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=159 Participants
|
|
Weight
|
9.45 kilograms
STANDARD_DEVIATION 2.32 • n=79 Participants
|
9.13 kilograms
STANDARD_DEVIATION 2.23 • n=80 Participants
|
9.30 kilograms
STANDARD_DEVIATION 2.28 • n=159 Participants
|
|
Time without liquids
|
6.93 hours
STANDARD_DEVIATION 3.82 • n=79 Participants
|
6.37 hours
STANDARD_DEVIATION 3.72 • n=80 Participants
|
6.66 hours
STANDARD_DEVIATION 3.77 • n=159 Participants
|
PRIMARY outcome
Timeframe: When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutesSuccess for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
Outcome measures
| Measure |
Infrared Vein Illumination
n=79 Participants
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
n=80 Participants
Standard vein location techniques will be used when inserting an intravenous access line
|
|---|---|---|
|
Success Rate
|
84.81 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: When patient is in operating room and insertion of intravenous access line is performedThe number of attempts it takes for successful insertion of the intravenous access line
Outcome measures
| Measure |
Infrared Vein Illumination
n=79 Participants
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
n=80 Participants
Standard vein location techniques will be used when inserting an intravenous access line
|
|---|---|---|
|
The Number of Attempts
|
1.93 number of attempts
Standard Deviation 1.46
|
2.15 number of attempts
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: When patient is in operating room and insertion of intravenous access line is performedThe time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established
Outcome measures
| Measure |
Infrared Vein Illumination
n=79 Participants
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Infrared illumination: Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
Standard Technique
n=80 Participants
Standard vein location techniques will be used when inserting an intravenous access line
|
|---|---|---|
|
Time to Successful Insertion
|
149.39 seconds
Standard Deviation 354.04
|
136.92 seconds
Standard Deviation 179.79
|
Adverse Events
Infrared Vein Illumination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Technique
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