Trial Outcomes & Findings for Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum (NCT NCT01853215)

Results Overview

The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

during 12 minutes of infusion

Results posted on

2013-10-18

Participant Flow

Healthy adults aged 21 years and older were recruited to participate in the study.

Participant milestones

Participant milestones
Measure	Sternal Intraosseous Vascular Access sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sternal Intraosseous Vascular Access n=24 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	33.4 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: during 12 minutes of infusion

Population: Per protocol

The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=24 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
Occurrences of Extravasation During Infusion	2 participants

SECONDARY outcome

Timeframe: During insertion of the intraosseous needle set

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=23 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
Stability of Locator	4.04 Likert scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=24 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
Stability of Catheter Hub	4.35 Likert scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: During insertion of the intraosseous needle set

Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=24 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
Adhesion Strips	3.83 Likert scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: during the 12 minute infusion time frame

Population: Per protocol

Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=23 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
Gravity Flow Rates	1130.44 milliliters per hour Standard Deviation 691.79

SECONDARY outcome

Timeframe: during the 12 minute infusion time frame

Population: Per protocol

Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=23 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
100mmHg Infusion Flow Rates	3373.91 milliliters per hour Standard Deviation 1370.21

SECONDARY outcome

Timeframe: during the 12 minute infusion time frame

Population: Per protocol

Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=21 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
200mmHg Infusion Flow Rates	4619.05 milliliters per hour Standard Deviation 1785.39

SECONDARY outcome

Timeframe: during the 12 minute infusion time frame

Population: Per protocol

Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.

Outcome measures

Outcome measures
Measure	Sternal Intraosseous Vascular Access n=22 Participants sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum
300mmHg Infusion Flow Rates	5327.27 milliliters per hour Standard Deviation 1724.39

Adverse Events

Sternal Intraosseous Vascular Access

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry J. Miller, MD

Vidacare Corporation

Phone: 210-375-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place