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The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.
This was a non-controlled study using licensed/certified EMT/paramedics and licensed nurses as device operator subjects identifying the proximal humerus IO insertion site and inserting the IO catheter in healthy adult volunteers. Forty (40) clinicians with no prior training on establishing IO vascular access in the proximal humerus IO insertion site were enrolled in the study as device operator subjects. Twenty (20) healthy adult volunteers were enrolled in the study to have IO vascular access established bilaterally in the proximal humerus with one device operator accessing one of the subject's arms, according to their assigned method for identifying the proximal humerus intraosseous vascular access site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vidacare Method for Intraosseous Insertion | Other | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. |
|
| Saussy Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
|
| Davlantes Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous Vascular Access | Other | Intraosseous vascular access in the proximal humerus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use Score | 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 Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use. | Within 10 minutes of procedure |
| Level of Confidence Score | Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence. | within 10 minutes of procedure |
| Proximal Humerus Intraosseous (IO) Insertion Site Placement Score | The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position. | within 10 minutes of the procedure |
| Time to Intraosseous (IO) 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. | within 10 minutes of the procedure |
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Inclusion Criteria Device Operators:
Exclusion Criteria Device Operators:
There is no exclusion criteria
Inclusion Criteria Healthy Volunteers
Exclusion Criteria Healthy Volunteers:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21856044 | Background | Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020. | |
| 21275573 | Background | Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28. |
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Healthy volunteers had a physical exam to confirm no excess tissue was overlaying the proximal humerus 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.
40 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. 20 healthy adults were recruited to receive PH IO vascular access in each PH using a different PH IO site identification method for each.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Vidacare Method for Intraosseous Insertion | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. |
| FG001 | Saussy Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| FG002 | Campbell Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| FG003 | Davlantes Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| FG004 | Healthy Subjects: Campbell and Saussy Methods | Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. |
| FG005 | Healthy Subjects: Davlantes and Standard Vidacare Methods | Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Vidacare Method for Intraosseous Insertion | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Ease of Use Score | 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 Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use. | One participant in the Davlantes Method for Intraosseous Insertion arm had their unilateral proximal humerus IO site insertion procedure terminated by the investigator. Since the procedure was terminated the participant did not complete the Ease of Use Question. Therefore only 9 participants were included in the Davlantes Method for Intraosseous Insertion arm analysis for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Within 10 minutes of procedure |
|
Adverse event data was collected over 2 days, including the day of the procedures and one day following.
Subjects were contacted one day following the procedures and asked if they experienced any adverse events in their arm/arms that received the IO device insertion
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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 | Campbell Method for Intraosseous Insertion | One participant in the Davlantes Method for Intraosseous Insertion arm had their unilateral proximal humerus IO site insertion procedure terminated by the investigator. Since the procedure was terminated the participant did not complete the questionnaire. Therefore only 9 unilateral proximal humerus were included in the Davlantes Method for Intraosseous Insertion arm analysis for this outcome measure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soreness Pain in Arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patients were contacted one day following the procedure and asked if they were experiencing any adverse events in their arm/arms that received the IO device insertion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Philbeck, PhD, Sr.Director Science and Clinical | Vidacare Corporation | 210-375-8500 | Thomas.Philbeck@Vidacare.com |
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|
| Campbell Method for Intraosseous Insertion | Other | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
|
| Healthy Subjects: Campbell and Saussy Methods | Other | Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. |
|
| Healthy Subject: Davlantes and Standard Vidacare Methods | Other | Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. |
|
| 22030185 | Background | Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24. |
| BG001 | Saussy Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| BG002 | Campbell Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| BG003 | Davlantes Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| BG004 | Healthy Subjects: Campbell and Saussy Methods | Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. |
| BG005 | Healthy Subjects: Davlantes and Standard Vidacare Methods | Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. |
| BG006 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sex: Female, Male | 20 participants participated in two arms:10 participants participated in both arms: Saussy Method Subjects and Campbell Method Subjects; 10 participants participated in both arms: Standard Vidacare Method Subject and Davlantes Method Subjects | Count of Participants | Participants |
|
| OG001 | Davlantes Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| OG002 | Saussy Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access |
| OG003 | Standard Vidacare Method for Intraosseous Insertion | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. |
|
|
| Primary | Level of Confidence Score | Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence. | One participant in the Davlantes Method for Intraosseous Insertion arm had their unilateral proximal humerus IO site insertion procedure terminated by the investigator. Since the procedure was terminated the participant did not complete the questionnaire. Therefore only 9 unilateral proximal humerus were included in the Davlantes Method for Intraosseous Insertion arm analysis for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | within 10 minutes of procedure |
|
|
|
| Primary | Proximal Humerus Intraosseous (IO) Insertion Site Placement Score | The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position. | One participant in the Davlantes Method for Intraosseous Insertion arm had their unilateral proximal humerus IO site insertion procedure terminated by the investigator. That insertion site placement was scored 0. | Posted | Mean | Standard Deviation | units on a scale | within 10 minutes of the procedure |
|
|
|
| Primary | Time to Intraosseous (IO) 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. | One participant in the Davlantes Method for Intraosseous Insertion arm had their unilateral proximal humerus IO site insertion procedure terminated by the investigator. Since the procedure was terminated there was no time to record. Therefore only 9 were included in the Davlantes Method for Intraosseous Insertion arm analysis for this outcome measure. | Posted | Mean | Standard Deviation | seconds | within 10 minutes of the procedure |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Davlantes Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Saussy Method for Intraosseous Insertion | Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Standard Vidacare Method for Intraosseous Insertion | Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | Healthy Subjects: Campbell and Saussy Methods | Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG005 | Healthy Subjects: Davlantes and Standard Vidacare Methods | Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus. | 0 | 10 | 0 | 10 | 9 | 10 |
|
| hematoma on the arm at the site of the intraosseous device insertion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patients were contacted one day following the procedure and asked if they were experiencing any adverse events in their arm/arms that received the IO device insertion. |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Male |
|