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The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Landmark group | Active Comparator | An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein. |
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| Ultrasound group | Active Comparator | An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saphenous vein cannulation | Procedure | Intravenous cannulation to saphenous vein |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. | 10 minutes | |
| Time Required for Overall Successful Venous Cannulation. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satoshi Hanada, MD | University of Iowa Hospitals & Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22037223 | Background | Triffterer L, Marhofer P, Willschke H, Machata AM, Reichel G, Benkoe T, Kettner SC. Ultrasound-guided cannulation of the great saphenous vein at the ankle in infants. Br J Anaesth. 2012 Feb;108(2):290-4. doi: 10.1093/bja/aer334. Epub 2011 Oct 27. | |
| 22134232 | Background | Riera A, Langhan M, Northrup V, Santucci K, Chen L. Remember the saphenous: ultrasound evaluation and intravenous site selection of peripheral veins in young children. Pediatr Emerg Care. 2011 Dec;27(12):1121-5. doi: 10.1097/PEC.0b013e31823ab926. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Landmark Group | An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein A 22 or 24 G intravenous catheter |
| FG001 | Ultrasound Group | An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein A 22 or 24 G intravenous catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Landmark Group | An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein A 22 or 24 G intravenous catheter |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation | Posted | Number | percent of participants | 10 minutes |
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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 | Landmark Group | An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein A 22 or 24 G intravenous catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Satoshi Hanada/Clinical Assistant Professor | University of Iowa Hopspital & Clinics | 3193561219 | satoshi-hanada@uiowa.edu |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| ultrasound with a linear transducer (L15-7io) | Device | Portable, bed-side ultrasound to detect saphenous vein |
|
| A 22 or 24 G intravenous catheter | Device |
|
| 20562139 | Background | Joshi M, Wilson G, Engelhardt T. Comparison of landmark technique and ultrasound guidance for localisation of long saphenous vein in infants and children. Emerg Med J. 2010 Jun;27(6):443-5. doi: 10.1136/emj.2008.069310. |
| BG001 | Ultrasound Group | An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein A 22 or 24 G intravenous catheter |
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. | Posted | Number | percent of participants | 10 minutes |
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| Secondary | Time Required for Overall Successful Venous Cannulation. | Includes only those participants for which successful cannulation was achieved. | Posted | Median | Inter-Quartile Range | Seconds | 10 minutes |
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| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Ultrasound Group | An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein. Saphenous vein cannulation: Intravenous cannulation to saphenous vein ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein A 22 or 24 G intravenous catheter | 0 | 51 | 0 | 51 |
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