An interventional study of Infrared illumination in Difficult Intravenous Access, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (\<2years)
The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.
Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line
Device: Infrared illumination
Standard vein location techniques will be used when inserting an intravenous access line
Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
Success Rate
Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
Time frame: When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes
The Number of Attempts
The number of attempts it takes for successful insertion of the intravenous access line
Time frame: When patient is in operating room and insertion of intravenous access line is performed
Time to Successful Insertion
The 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
Time frame: When patient is in operating room and insertion of intravenous access line is performed
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.
| Milestone | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Started | 80 | 80 |
| Completed | 79 | 80 |
| Not completed | 1 | 0 |
| Withdrew: Subject withdrawn because research physician could not make it in time to place iv | 1 | 0 |
Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
| percentage of participants | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Success Rate | 84.81 | 90 |
The number of attempts it takes for successful insertion of the intravenous access line
| number of attempts | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| The Number of Attempts | 1.93 ± 1.46 | 2.15 ± 3.11 |
The 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
| seconds | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Time to Successful Insertion | 149.39 ± 354.04 | 136.92 ± 179.79 |
Collected over During the procedure up to their discharge from Post-anesthesia care unit or recovery unit up to 1 hour after the procedure, an average of 3 hours total. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infrared Vein Illumination | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
| Standard Technique | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(months) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Mean | 13.11 ± 6.19 | 12.42 ± 6.44 | 12.76 ± 6.31 |
| Sex: Female, Male(Participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Female | 36 | 38 | 74 |
| Male | 43 | 42 | 85 |
| Race/Ethnicity, Customized(participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Caucasian | 60 | 56 | 116 |
| African American | 5 | 8 | 13 |
| Hispanic/Latino | 8 | 10 | 18 |
| Asian | 2 | 2 | 4 |
| Mixed Race | 3 | 2 | 5 |
| Other | 1 | 1 | 2 |
| Unknown | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| United States | 79 | 80 | 159 |
| Skin Color(Participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Light | 60 | 57 | 117 |
| Medium | 15 | 18 | 33 |
| Dark | 4 | 4 | 8 |
| Anticipated IV access difficulty(participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| 0 | 0 | 5 | 5 |
| 1 | 14 | 9 | 23 |
| 2 | 22 | 19 | 41 |
| 3 | 23 | 26 | 49 |
| 4 | 11 | 11 | 22 |
| 5 | 9 | 9 | 18 |
| Prematurity(Participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| yes | 13 | 12 | 25 |
| no | 65 | 68 | 133 |
| ASA physical Status(Participants) | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| 1 | 19 | 21 | 40 |
| 2 | 47 | 43 | 90 |
| 3 | 13 | 16 | 29 |
| 4 | 0 | 0 | 0 |
| 5 | 0 | 0 | 0 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center