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A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blended Technique for Intraosseous Insertion | Other | 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 | Other | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Vascular Access | Device | Intraossesous Vascular Access in the proximal humerus |
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| Measure | Description | Time Frame |
|---|---|---|
| Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score | 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). | Day 1 Within 10 minutes following procedure |
| Time to Intraosseous Catheter Placement | 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. | 1 day, within 10 minutes of procedure |
| Level of Confidence Score Pre-intraosseous Insertion | 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. | Day 1 within 10 minutes of completing training |
| Level of Confidence Score Post-intraosseous Insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Intraosseous Infusion Flow Rates | Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg. | Day 1 after establishing IO vascular access |
| Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart |
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Inclusion Criteria Device Operators:
Exclusion Criteria for Device Operators: None
Inclusion Criteria Healthy Subjects:
Exclusion Criteria Health Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Larry J Miller, MD | Vidacare Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bulverde-Spring Branch EMS | Spring Branch | Texas | 78070 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score | 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). | Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group | Posted | Mean | Standard Deviation | units on a scale | Day 1 Within 10 minutes following procedure |
Adverse events were collected over 2 days, including the Day 1 study procedure day and 1 day following.
Adverse events were assessed on Day 1 for both study arms. Participants in the Healthy Subjects: Blended Technique arm were also contact 1 day following to ask if they experienced any adverse events in their arm/arms that received the Intraosseous Insertion device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Puga | Teleflex | tatiana.puga@teleflex.com |
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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. |
| Day 1 within 10 minutes of completing the unilateral intraosseous insertion |
| Ease of Use Score Pre-intraosseous Insertion | 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. | Day 1 within 10 minutes of completing the unilateral intraosseous insertion |
| Ease of Use Score Post-intraosseous Insertion | 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. | Day 1 within 10 minutes of completing the unilateral insertion |
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. |
| Day 1 after IO insertion |
| Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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 | Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | 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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| Primary | Time to Intraosseous Catheter Placement | 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. | 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. | Posted | Mean | Standard Deviation | seconds | 1 day, within 10 minutes of procedure |
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| Primary | Level of Confidence Score Pre-intraosseous Insertion | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 within 10 minutes of completing training |
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| Primary | Level of Confidence Score Post-intraosseous Insertion | 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. | Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group. | Posted | Mean | Standard Deviation | units on a scale | Day 1 within 10 minutes of completing the unilateral intraosseous insertion |
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| Primary | Ease of Use Score Pre-intraosseous Insertion | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 within 10 minutes of completing the unilateral intraosseous insertion |
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| Primary | Ease of Use Score Post-intraosseous Insertion | 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. | Pre-specified to only evaluate participants in the Blended Technique for Intraosseous Insertion group. | Posted | Mean | Standard Deviation | units on a scale | Day 1 within 10 minutes of completing the unilateral insertion |
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| Secondary | Intraosseous Infusion Flow Rates | Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg. | Intraosseous infusion flowrate measurement was not performed for any participants, at the discretion of the principal investigator, due to equipment issues. | Posted | Mean | Standard Deviation | mL / hour | Day 1 after establishing IO vascular access |
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| Secondary | Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart | 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. | 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. | Posted | Mean | Standard Deviation | seconds | Day 1 after IO insertion |
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| Secondary | Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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 | Pre-specified to only evaluate participants in the Healthy Subjects: Blended Technique group | Posted | Count of Participants | Participants | Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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