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The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| disposable elastic tourniquet | Active Comparator |
| |
| manual blood pressure cuff | Active Comparator | manual blood pressure cuff inflated to 150 milliliters mercury (mmHg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable elastic tourniquet | Device | Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral IV Access Success Rate | Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Peripheral IV Access Attempts | The total number of peripheral IV access attempts for each subject., up to a maximum of four attempts. An attempt is defined as a needle penetrating the subject's skin surface. | baseline |
| Total Number of Distinct Providers That Attempted IV Access |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kummer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30948254 | Result | Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Disposable Elastic Tourniquet | disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. |
| FG001 | Manual Blood Pressure Cuff | manual blood pressure cuff inflated to 150 milliliters mercury (mmHg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Disposable Elastic Tourniquet | disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. |
| BG001 | Manual Blood Pressure Cuff |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Peripheral IV Access Success Rate | Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection. | Posted | Count of Participants | Participants | baseline |
|
Adverse event data were collected during the duration of the IV placement during the emergency department visit, approximately 45 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 | Disposable Elastic Tourniquet | disposable elastic tourniquet: Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tobias Kummer | Mayo Clinic | 507-255-4399 | kummer.tobias@mayo.edu |
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| blood pressure cuff | Device | Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff. |
|
Total number of individual medical providers that attempt to access IV for each subject. An attempt is defined as a needle penetrating the surface of the subject's skin. Access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection. |
| baseline |
| Rate of Rescue Techniques Used | The number of subjects requiring one or more rescue techniques to access peripheral IV. These techniques include ultrasound guided peripheral IV access, central venous access, venous cut-down, interosseous access, and/or change in treatment plan due to unsuccessful access. | baseline |
manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
|
|
|
| Secondary | Total Number of Peripheral IV Access Attempts | The total number of peripheral IV access attempts for each subject., up to a maximum of four attempts. An attempt is defined as a needle penetrating the subject's skin surface. | Posted | Count of Participants | Participants | baseline |
|
|
|
|
| Secondary | Total Number of Distinct Providers That Attempted IV Access | Total number of individual medical providers that attempt to access IV for each subject. An attempt is defined as a needle penetrating the surface of the subject's skin. Access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection. | Posted | Count of Participants | Participants | baseline |
|
|
|
|
| Secondary | Rate of Rescue Techniques Used | The number of subjects requiring one or more rescue techniques to access peripheral IV. These techniques include ultrasound guided peripheral IV access, central venous access, venous cut-down, interosseous access, and/or change in treatment plan due to unsuccessful access. | Posted | Count of Participants | Participants | baseline |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Manual Blood Pressure Cuff | manual blood pressure cuff inflated to 150 milliliters mercury (mmHg) | 0 | 60 | 0 | 60 | 0 | 60 |
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| Three attempts |
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| Four attempts |
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| Three providers |
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