An interventional study of disposable elastic tourniquet and blood pressure cuff in Tourniquet, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-20.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: disposable elastic tourniquet
manual blood pressure cuff inflated to 150 milliliters mercury (mmHg)
Device: blood pressure cuff
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
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.
Time frame: baseline
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.
Time frame: baseline
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.
Time frame: 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.
Time frame: baseline
| Milestone | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff |
|---|---|---|
| Started | 59 | 60 |
| Completed | 59 | 60 |
| Not completed | 0 | 0 |
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.
| Participants | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff |
|---|---|---|
| Peripheral IV Access Success Rate | 42 | 43 |
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.
| Participants | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff |
|---|---|---|
| One attempt | 42 | 43 |
| Two attempts | 13 | 9 |
| Three attempts | 3 | 6 |
| Four attempts | 1 | 2 |
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.
| Participants | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff |
|---|---|---|
| One provider | 51 | 50 |
| Two providers | 7 | 10 |
| Three providers | 1 | 0 |
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.
| Participants | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff |
|---|---|---|
| Rate of Rescue Techniques Used | 6 | 3 |
Collected over Adverse event data were collected during the duration of the IV placement during the emergency department visit, approximately 45 minutes.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Disposable Elastic Tourniquet | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Manual Blood Pressure Cuff | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff | Total |
|---|---|---|---|
| Median | 67 (54 to 78) | 62 (41 to 75) | 65 (46 to 77) |
| Sex: Female, Male(Participants) | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff | Total |
|---|---|---|---|
| Female | 33 | 35 | 68 |
| Male | 26 | 25 | 51 |
| Race and Ethnicity Not Collected(Participants) | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Disposable Elastic Tourniquet | Manual Blood Pressure Cuff | Total |
|---|---|---|---|
| United States | 59 | 60 | 119 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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