Trial Outcomes & Findings for Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site (NCT NCT01866501)
NCT ID: NCT01866501
Last Updated: 2026-05-14
Results Overview
X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below. The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy. Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle. Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).
COMPLETED
NA
15 participants
Day 1 Within 10 minutes following procedure
2026-05-14
Participant Flow
10 licensed/certified clinicians with no prior training on establishing intraosseous (IO) vascular access in the proximal humerus (PH) were recruited for participation as device operators to learn one PH IO site identification method and perform one unilateral proximal humerus IO site insertion procedure. 5 healthy adults were recruited to receive bilateral PH IO vascular access using the PH IO site identification method.
Healthy volunteers had a physical exam to confirm no excess tissue was overlaying the proximal humerus intraosseous (IO) insertion site and adequate landmarks were visible. Clinicians were trained on and had to correctly demonstrate their assigned method for IO vascular access in the proximal humerus for approval to participate as a device operator.
Participant milestones
| Measure |
Blended Technique for Intraosseous Insertion
Clinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen
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Healthy Subjects: Blended Technique
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|---|
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Overall Study
STARTED
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10
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5
|
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Overall Study
COMPLETED
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10
|
5
|
|
Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blended Technique for Intraosseous Insertion
n=10 Participants
Clinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen
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Healthy Subjects: Blended Technique
n=5 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
|
Total
n=15 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=10 Participants
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0 Participants
n=5 Participants
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0 Participants
n=15 Participants
|
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=10 Participants
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5 Participants
n=5 Participants
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15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
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Sex: Female, Male
Female
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7 Participants
n=10 Participants
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3 Participants
n=5 Participants
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10 Participants
n=15 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=10 Participants
|
2 Participants
n=5 Participants
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5 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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10 Participants
n=10 Participants
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5 Participants
n=5 Participants
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15 Participants
n=15 Participants
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PRIMARY outcome
Timeframe: Day 1 Within 10 minutes following procedurePopulation: Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group
X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below. The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy. Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle. Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=10 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score
Total Score
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6.0 units on a scale
Standard Deviation 4.7
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Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score
Insertion site accuracy score
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1.2 units on a scale
Standard Deviation 1.2
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Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score
Needle tip location score
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4.8 units on a scale
Standard Deviation 3.8
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PRIMARY outcome
Timeframe: 1 day, within 10 minutes of procedurePopulation: Time to intraosseous catheter placement was not completed for 4 of the 10 device operators (participants in the Blended Technique for Intraosseous Insertion group). Therefore data for only 6 was included in the analysis. Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group.
The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle. Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=6 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Time to Intraosseous Catheter Placement
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178.0 seconds
Standard Deviation 37.6
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PRIMARY outcome
Timeframe: Day 1 within 10 minutes of completing trainingPopulation: Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group. Level of confidence score pre-intraosseous infusion was not captured for 1 of 10 device operators (participants in the Blended Technique for Intraosseous Insertion group). Therefore, only 9 are included in the analysis.
Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method. The score was reported following the completion of training but before performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=9 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Level of Confidence Score Pre-intraosseous Insertion
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3.22 units on a scale
Standard Deviation 0.83
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PRIMARY outcome
Timeframe: Day 1 within 10 minutes of completing the unilateral intraosseous insertionPopulation: Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group.
Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=10 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Level of Confidence Score Post-intraosseous Insertion
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4.1 units on a scale
Standard Deviation 0.87
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PRIMARY outcome
Timeframe: Day 1 within 10 minutes of completing the unilateral intraosseous insertionPopulation: Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group. Ease of use score pre-intraosseous infusion was not captured for 1 of 10 device operators (participants in the Blended Technique for Intrasosseous Insertion group). Therefore, only 9 are included in analysis.
Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported following the completion of training but before performing the unilateral IO insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=9 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
|
|---|---|
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Ease of Use Score Pre-intraosseous Insertion
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4.11 units on a scale
Standard Deviation 0.60
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PRIMARY outcome
Timeframe: Day 1 within 10 minutes of completing the unilateral insertionPopulation: Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group.
Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after completing the unilateral intraosseous insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=10 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
|
|---|---|
|
Ease of Use Score Post-intraosseous Insertion
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4.5 units on a scale
Standard Deviation 0.97
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SECONDARY outcome
Timeframe: Day 1 after establishing IO vascular accessPopulation: Intraosseous infusion flowrate measurement was not performed for any participants, at the discretion of the principal investigator, due to equipment issues.
Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 after IO insertionPopulation: Time in seconds for fluid delivery from the proximal humerus to the heart was not measured for 2 of 5 participants in the Health Subjects: Blended Technique arm. Therefore only 3 are included in the analysis.
Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy was performed and measured once for the participants in the Healthy Subjects: Blended Technique arm.
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=3 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart
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2.44 seconds
Standard Deviation 0.10
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SECONDARY outcome
Timeframe: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous accessPopulation: Pre-specified to only evaluate participants in the Healthy Subjects: Blended Technique group
Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject
Outcome measures
| Measure |
Healthy Subjects: Blended Technique
n=5 Participants
Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.
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|---|---|
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Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens
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4 Participants
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Adverse Events
Blended Technique for Intraosseous Insertion
Healthy Subjects: Blended Technique
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place