混合技術を検証する追跡調査

他の：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

デバイス：Intraosseous Vascular Access

Intraossesous Vascular Access in the proximal humerus

他の名前：

• イージーイオ
• IO
• 上腕骨近位IOアクセス

他の：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.

デバイス：Intraosseous Vascular Access

Intraossesous Vascular Access in the proximal humerus

他の名前：

• イージーイオ
• IO
• 上腕骨近位IOアクセス

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).

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.

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.

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.

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.

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.

Intraosseous Infusion Flow Rates

Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.

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.

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