Tourniquet
Conditions
Keywords
peripheral intravenous access, tourniquet techniques
Brief summary
The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.
Interventions
DEVICEdisposable elastic tourniquet
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
DEVICEblood pressure cuff
Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency Department patients * 18 years old or older * who receive peripheral IV access
Exclusion criteria
* Patients under the age of 18 * prison inmates * pregnant patients * patients who are unable to give informed consent * critically ill patients who need emergent IV access as defined by the Emergency Medicine consultant of record for the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral IV Access Success Rate | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Peripheral IV Access Attempts | baseline | 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. |
| Total Number of Distinct Providers That Attempted IV Access | baseline | 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. |
| Rate of Rescue Techniques Used | baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| Manual Blood Pressure Cuff manual blood pressure cuff inflated to 150 milliliters mercury (mmHg) | 60 |
| Total | 119 |
Baseline characteristics
| Characteristic | Manual Blood Pressure Cuff | Total | Disposable Elastic Tourniquet |
|---|---|---|---|
| Age, Continuous | 62 years | 65 years | 67 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 60 Participants | 119 Participants | 59 Participants |
| Sex: Female, Male Female | 35 Participants | 68 Participants | 33 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 60 |
| other Total, other adverse events | 0 / 59 | 0 / 60 |
| serious Total, serious adverse events | 0 / 59 | 0 / 60 |
Outcome results
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.
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Disposable Elastic Tourniquet | Peripheral IV Access Success Rate | 42 Participants |
| Manual Blood Pressure Cuff | Peripheral IV Access Success Rate | 43 Participants |
p-value: 0.95Wilcoxon (Mann-Whitney)
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.
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Disposable Elastic Tourniquet | Rate of Rescue Techniques Used | 6 Participants |
| Manual Blood Pressure Cuff | Rate of Rescue Techniques Used | 3 Participants |
p-value: 0.32Wilcoxon (Mann-Whitney)
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.
Time frame: baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Disposable Elastic Tourniquet | Total Number of Distinct Providers That Attempted IV Access | One provider | 51 Participants |
| Disposable Elastic Tourniquet | Total Number of Distinct Providers That Attempted IV Access | Two providers | 7 Participants |
| Disposable Elastic Tourniquet | Total Number of Distinct Providers That Attempted IV Access | Three providers | 1 Participants |
| Manual Blood Pressure Cuff | Total Number of Distinct Providers That Attempted IV Access | Two providers | 10 Participants |
| Manual Blood Pressure Cuff | Total Number of Distinct Providers That Attempted IV Access | One provider | 50 Participants |
| Manual Blood Pressure Cuff | Total Number of Distinct Providers That Attempted IV Access | Three providers | 0 Participants |
p-value: 0.67Wilcoxon (Mann-Whitney)
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.
Time frame: baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Disposable Elastic Tourniquet | Total Number of Peripheral IV Access Attempts | One attempt | 42 Participants |
| Disposable Elastic Tourniquet | Total Number of Peripheral IV Access Attempts | Three attempts | 3 Participants |
| Disposable Elastic Tourniquet | Total Number of Peripheral IV Access Attempts | Two attempts | 13 Participants |
| Disposable Elastic Tourniquet | Total Number of Peripheral IV Access Attempts | Four attempts | 1 Participants |
| Manual Blood Pressure Cuff | Total Number of Peripheral IV Access Attempts | Two attempts | 9 Participants |
| Manual Blood Pressure Cuff | Total Number of Peripheral IV Access Attempts | One attempt | 43 Participants |
| Manual Blood Pressure Cuff | Total Number of Peripheral IV Access Attempts | Four attempts | 2 Participants |
| Manual Blood Pressure Cuff | Total Number of Peripheral IV Access Attempts | Three attempts | 6 Participants |
p-value: 0.87Wilcoxon (Mann-Whitney)