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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infrared vein illumination | Experimental | Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line |
|
| Standard Technique | No Intervention | Standard vein location techniques will be used when inserting an intravenous access line |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrared illumination | Device | Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline | When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Attempts | The number of attempts it takes for successful insertion of the intravenous access line | When patient is in operating room and insertion of intravenous access line is performed |
| Time to Successful Insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priti G Dalal, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22694242 | Background | 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. | |
| 26391665 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Technique | Standard vein location techniques will be used when inserting an intravenous access line |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate | Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline | Posted | Number | percentage of participants | When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Priti Dalal | Penn State Hershey Medical Center | 717-531-6597 | pdalal@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2021 | Oct 7, 2021 | Prot_SAP_000.pdf |
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Randomized, controlled trial
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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
| When patient is in operating room and insertion of intravenous access line is performed |
| Rothbart A, Yu P, Muller-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. |
| 23763614 | Background | 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. |
| 19922428 | Background | 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. |
| 16157191 | Background | 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. doi: 10.1016/j.hrtlng.2005.04.002. |
| 18347490 | Background | 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. |
| Standard Technique |
Standard vein location techniques will be used when inserting an intravenous access line |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Skin Color | Skin color data was not collected from 1 standard subject | Count of Participants | Participants |
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| Anticipated IV access difficulty | Anticipated IV access difficulty is scored on a subjective Likert Scale where 0 is no anticipated difficulty and 5 is extreme anticipated difficulty | Data was not collected for the anticipated IV access difficulty for 1 standard subject | Number | participants |
|
| Prematurity | Prematurity is defined as live birth prior to 37 weeks gestation | Prematurity data was not entered for 1 Infrared vein illumination subject | Count of Participants | Participants |
|
| ASA physical Status | ASA1=healthy patients ASA2=mild to moderate systemic disease caused by the surgical condition or by other pathological processes, and are medically well controlled ASA3=severe disease process which limits activity but is not incapacitating ASA4=severe disease process that is a constant threat to life ASA5=moribund patient not expected to survive 24 hours with or without an operation ASA6=Declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Time without liquids | Mean | Standard Deviation | hours |
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| Secondary | The Number of Attempts | The number of attempts it takes for successful insertion of the intravenous access line | Posted | Mean | Standard Deviation | number of attempts | When patient is in operating room and insertion of intravenous access line is performed |
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| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | When patient is in operating room and insertion of intravenous access line is performed |
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| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Standard Technique | Standard vein location techniques will be used when inserting an intravenous access line | 0 | 80 | 0 | 80 | 0 | 80 |
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| Dark |
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| 3 |
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| 4 |
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| 5 |
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