Intraosseous Vascular Access
Conditions
Keywords
sternal intraosseous infusion study
Brief summary
This study is being done to evaluate intraosseous vascular access through the sternum.
Detailed description
The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.
Interventions
DEVICET.A.L.O.N. Intraosseous System
intraosseous catheter for use in the sternum
Sponsors
Vidacare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 21 years of age or older; * healthy adult subjects
Exclusion criteria
* Weight \< 45kg; * BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI; * Imprisoned subjects; * pregnant subjects; * prior sternotomy; * cognitively impaired subjects; * fracture in target bone, or significant trauma to the site; * excessive tissue and/or absence of adequate anatomical landmarks in target bone; * infection in target area; * IO insertion in past 48 hours or other significant orthopedic procedure in target bone; * current use of anti-coagulants; * previous adverse reaction to Lidocaine; * current cardiac condition requiring pacemaker or anti-arrhythmic drugs * previous adverse reaction to contrast dye * Allergy to any food and drug * History of impaired renal function * History of impaired hepatic function * History of cardiac disease * History of pheochromocytoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrences of Extravasation During Infusion | during 12 minutes of infusion | The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability of Catheter Hub | During insertion of the intraosseous needle set | Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy. |
| Adhesion Strips | During insertion of the intraosseous needle set | Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. |
| Gravity Flow Rates | during the 12 minute infusion time frame | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure). |
| Stability of Locator | During insertion of the intraosseous needle set | Operator's perceived stability of the sternal locator once placed on the subject. 1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. |
| 200 Millimeters of Mercury (mmHg) Infusion Flow Rates | during the 12 minute infusion time frame | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion. |
| 300 Millimeters of Mercury (mmHg) Infusion Flow Rates | during the 12 minute infusion time frame | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion. |
| 100 Millimeters of Mercury (mmHg) Infusion Flow Rates | during the 12 minute infusion time frame | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion. |
Countries
United States
Participant flow
Recruitment details
Healthy adults aged 21 years and older were recruited to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Sternal Intraosseous Vascular Access sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set
T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Sternal Intraosseous Vascular Access |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 33.4 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Occurrences of Extravasation During Infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
Time frame: during 12 minutes of infusion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sternal Intraosseous Vascular Access | Occurrences of Extravasation During Infusion | 2 participants |
Secondary
100 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.
Time frame: during the 12 minute infusion time frame
Population: One participant experienced a prior extravasation and therefore did not receive the 100 mmHG flowrate infusion. Only 23 participants were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | 100 Millimeters of Mercury (mmHg) Infusion Flow Rates | 3373.91 milliliters per hour | Standard Deviation 1370.21 |
Secondary
200 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.
Time frame: during the 12 minute infusion time frame
Population: Two participants experienced a prior extravasation and therefore did not receive the 200 mmHg flowrate infusion. For one participant the 200 mmHg flowrate infusion was not performed. Therefore only 21 participants were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | 200 Millimeters of Mercury (mmHg) Infusion Flow Rates | 4619.05 milliliters per hour | Standard Deviation 1785.39 |
Secondary
300 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.
Time frame: during the 12 minute infusion time frame
Population: Two subjects experienced a prior extravasation and therefore did not receive the 300 mmHg flowrate infusion. Thus only 22 subjects were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | 300 Millimeters of Mercury (mmHg) Infusion Flow Rates | 5327.27 milliliters per hour | Standard Deviation 1724.39 |
Secondary
Adhesion Strips
Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent.
Time frame: During insertion of the intraosseous needle set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | Adhesion Strips | 3.83 Likert scale | Standard Deviation 1.13 |
Secondary
Gravity Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).
Time frame: during the 12 minute infusion time frame
Population: One participant experienced a prior extravasation and therefore did not receive the gravity flowrate infusion. Only 23 participants were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | Gravity Flow Rates | 1130.44 milliliters per hour | Standard Deviation 691.79 |
Secondary
Stability of Catheter Hub
Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.
Time frame: During insertion of the intraosseous needle set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | Stability of Catheter Hub | 4.35 Likert scale | Standard Deviation 0.8 |
Secondary
Stability of Locator
Operator's perceived stability of the sternal locator once placed on the subject. 1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent.
Time frame: During insertion of the intraosseous needle set
Population: This outcome measure was not reported for one participant, thus only 23 participants were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sternal Intraosseous Vascular Access | Stability of Locator | 4.04 Likert scale | Standard Deviation 1.15 |