Infra Red Vein Visualization: Efficacy vs. Standard Technique
Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03181542
Collaborator
(none)
160
1
2
39.7
4
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, controlled trialRandomized, controlled trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique
Actual Study Start Date
:
Jul 10, 2017
Actual Primary Completion Date
:
Oct 29, 2020
Actual Study Completion Date
:
Oct 29, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Device: Infrared illumination
Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
|
| No Intervention: Standard Technique Standard vein location techniques will be used when inserting an intravenous access line |
Outcome Measures
Primary Outcome Measures
- Success Rate [When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes]
Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline
Secondary Outcome Measures
- The Number of Attempts [When patient is in operating room and insertion of intravenous access line is performed]
The number of attempts it takes for successful insertion of the intravenous access line
- Time to Successful Insertion [When patient is in operating room and insertion of intravenous access line is performed]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Children(<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital
-
ASA physical status 1,2 or 3
Exclusion Criteria:
-
Emergency procedures requiring anesthesia
-
ASA physical status 4
-
Patients with pre existing iv access
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Priti G Dalal, MD, Milton S. Hershey Medical Center
Study Documents (Full-Text)
More Information
Publications
- de Graaff JC, Cuper NJ, Mungra RA, Vlaardingerbroek K, Numan SC, Kalkman CJ. Near-infrared light to aid peripheral intravenous cannulation in children: a cluster randomised clinical trial of three devices. Anaesthesia. 2013 Aug;68(8):835-45. doi: 10.1111/anae.12294. Epub 2013 Jun 14.
- Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59.
- Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.
- Nafiu OO, Burke C, Cowan A, Tutuo N, Maclean S, Tremper KK. Comparing peripheral venous access between obese and normal weight children. Paediatr Anaesth. 2010 Feb;20(2):172-6. doi: 10.1111/j.1460-9592.2009.03198.x. Epub 2009 Nov 17.
- Rothbart A, Yu P, Müller-Lobeck L, Spies CD, Wernecke KD, Nachtigall I. Peripheral intravenous cannulation with support of infrared laser vein viewing system in a pre-operation setting in pediatric patients. BMC Res Notes. 2015 Sep 21;8:463. doi: 10.1186/s13104-015-1431-2.
- Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
Responsible Party:
Priti G. Dalal,
Professor of Anesthesiology & Perioperative Medicine,
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT03181542
Other Study ID Numbers:
- STUDY00006768
First Posted:
Jun 8, 2017
Last Update Posted:
Dec 21, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line |
| Period Title: Overall Study | ||
| STARTED | 80 | 80 |
| COMPLETED | 79 | 80 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Infrared Vein Illumination | Standard Technique | Total |
|---|---|---|---|
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line | Total of all reporting groups |
| Overall Participants | 79 | 80 | 159 |
| Age (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
13.11
(6.19)
|
12.42
(6.44)
|
12.76
(6.31)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
36
45.6%
|
38
47.5%
|
74
46.5%
|
| Male |
43
54.4%
|
42
52.5%
|
85
53.5%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
60
75.9%
|
56
70%
|
116
73%
|
| African American |
5
6.3%
|
8
10%
|
13
8.2%
|
| Hispanic/Latino |
8
10.1%
|
10
12.5%
|
18
11.3%
|
| Asian |
2
2.5%
|
2
2.5%
|
4
2.5%
|
| Mixed Race |
3
3.8%
|
2
2.5%
|
5
3.1%
|
| Other |
1
1.3%
|
1
1.3%
|
2
1.3%
|
| Unknown |
0
0%
|
1
1.3%
|
1
0.6%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
79
100%
|
80
100%
|
159
100%
|
| Skin Color (Count of Participants) | |||
| Light |
60
75.9%
|
57
71.3%
|
117
73.6%
|
| Medium |
15
19%
|
18
22.5%
|
33
20.8%
|
| Dark |
4
5.1%
|
4
5%
|
8
5%
|
| Anticipated IV access difficulty (participants) [Number] | |||
| 0 |
0
0%
|
5
6.3%
|
5
3.1%
|
| 1 |
14
17.7%
|
9
11.3%
|
23
14.5%
|
| 2 |
22
27.8%
|
19
23.8%
|
41
25.8%
|
| 3 |
23
29.1%
|
26
32.5%
|
49
30.8%
|
| 4 |
11
13.9%
|
11
13.8%
|
22
13.8%
|
| 5 |
9
11.4%
|
9
11.3%
|
18
11.3%
|
| Prematurity (Count of Participants) | |||
| yes |
13
16.5%
|
12
15%
|
25
15.7%
|
| no |
65
82.3%
|
68
85%
|
133
83.6%
|
| ASA physical Status (Count of Participants) | |||
| 1 |
19
24.1%
|
21
26.3%
|
40
25.2%
|
| 2 |
47
59.5%
|
43
53.8%
|
90
56.6%
|
| 3 |
13
16.5%
|
16
20%
|
29
18.2%
|
| 4 |
0
0%
|
0
0%
|
0
0%
|
| 5 |
0
0%
|
0
0%
|
0
0%
|
| Weight (kilograms) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms] |
9.45
(2.32)
|
9.13
(2.23)
|
9.30
(2.28)
|
| Time without liquids (hours) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [hours] |
6.93
(3.82)
|
6.37
(3.72)
|
6.66
(3.77)
|
Outcome Measures
| Title | Success Rate |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line |
| Measure Participants | 79 | 80 |
| Number [percentage of participants] |
84.81
107.4%
|
90
112.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Infrared Vein Illumination, Standard Technique |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | The Number of Attempts |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line |
| Measure Participants | 79 | 80 |
| Mean (Standard Deviation) [number of attempts] |
1.93
(1.46)
|
2.15
(3.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Infrared Vein Illumination, Standard Technique |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | Jonckheere-Terpstra Test | |
| Comments | ||
| Title | Time to Successful Insertion |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Infrared Vein Illumination | Standard Technique |
|---|---|---|
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line |
| Measure Participants | 79 | 80 |
| Mean (Standard Deviation) [seconds] |
149.39
(354.04)
|
136.92
(179.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Infrared Vein Illumination, Standard Technique |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Jonckheere-Terpstra Test | |
| Comments | ||
Adverse Events
| Time Frame | 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 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Infrared Vein Illumination | Standard Technique | ||
| Arm/Group Description | 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 vein location techniques will be used when inserting an intravenous access line | ||
All Cause Mortality |
||||
| Infrared Vein Illumination | Standard Technique | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/79 (0%) | 0/80 (0%) | ||
Serious Adverse Events |
||||
| Infrared Vein Illumination | Standard Technique | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/79 (0%) | 0/80 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Infrared Vein Illumination | Standard Technique | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/79 (0%) | 0/80 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr Priti Dalal |
|---|---|
| Organization | Penn State Hershey Medical Center |
| Phone | 717-531-6597 |
| pdalal@pennstatehealth.psu.edu |
Responsible Party:
Priti G. Dalal,
Professor of Anesthesiology & Perioperative Medicine,
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT03181542
Other Study ID Numbers:
- STUDY00006768
First Posted:
Jun 8, 2017
Last Update Posted:
Dec 21, 2021
Last Verified:
Nov 1, 2021