Trial Outcomes & Findings for Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site (NCT NCT01742780)

NCT ID: NCT01742780

Last Updated: 2026-04-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Within 10 minutes of procedure

Results posted on

2026-04-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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.
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
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
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
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.
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.
Overall Study
NOT COMPLETED
0
0
0
1
0
0
Overall Study
STARTED
10
10
10
10
10
10
Overall Study
COMPLETED
10
10
10
9
10
10

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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
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
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
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.
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.
Overall Study
Physician Decision
0
0
0
1
0
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Davlantes Method for Intraosseous Insertion
n=10 Participants
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
Healthy Subjects: Campbell and Saussy Methods
n=10 Participants
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 Subjects: Davlantes and Standard Vidacare Methods
n=10 Participants
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.
Total
n=60 Participants
Total of all reporting groups
Standard Vidacare Method for Intraosseous Insertion
n=10 Participants
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
n=10 Participants
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
Campbell Method for Intraosseous Insertion
n=10 Participants
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
Age, Categorical
>=65 years
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=60 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
Sex: Female, Male
Female
2 Participants
n=10 Participants • 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
1 Participants
n=10 Participants • 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
4 Participants
n=10 Participants • 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
16 Participants
n=60 Participants • 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
1 Participants
n=10 Participants • 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
3 Participants
n=10 Participants • 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
5 Participants
n=10 Participants • 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
Sex: Female, Male
Male
8 Participants
n=10 Participants • 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
9 Participants
n=10 Participants • 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
6 Participants
n=10 Participants • 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
44 Participants
n=60 Participants • 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
9 Participants
n=10 Participants • 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
7 Participants
n=10 Participants • 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
5 Participants
n=10 Participants • 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
Age, Categorical
<=18 years
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=60 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=10 Participants
10 Participants
n=10 Participants
10 Participants
n=10 Participants
60 Participants
n=60 Participants
10 Participants
n=10 Participants
10 Participants
n=10 Participants
10 Participants
n=10 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
10 participants
n=10 Participants
10 participants
n=10 Participants
10 participants
n=10 Participants
60 participants
n=60 Participants
10 participants
n=10 Participants
10 participants
n=10 Participants
10 participants
n=10 Participants

PRIMARY outcome

Timeframe: Within 10 minutes of procedure

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Campbell Method for Intraosseous Insertion
n=10 Participants
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
Davlantes Method for Intraosseous Insertion
n=9 Participants
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
Saussy Method for Intraosseous Insertion
n=10 Participants
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
Standard Vidacare Method for Intraosseous Insertion
n=10 Participants
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.
Ease of Use Score
9.60 units on a scale
Standard Deviation .70
8.33 units on a scale
Standard Deviation 1.73
8.60 units on a scale
Standard Deviation 2.32
8.30 units on a scale
Standard Deviation .95

PRIMARY outcome

Timeframe: within 10 minutes of procedure

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Campbell Method for Intraosseous Insertion
n=10 Participants
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
Davlantes Method for Intraosseous Insertion
n=9 Participants
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
Saussy Method for Intraosseous Insertion
n=10 Participants
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
Standard Vidacare Method for Intraosseous Insertion
n=10 Participants
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.
Level of Confidence Score
9.30 units on a scale
Standard Deviation .95
7.22 units on a scale
Standard Deviation 1.79
9.00 units on a scale
Standard Deviation .94
8.00 units on a scale
Standard Deviation 1.49

PRIMARY outcome

Timeframe: within 10 minutes of the procedure

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Campbell Method for Intraosseous Insertion
n=10 Participants
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
Davlantes Method for Intraosseous Insertion
n=10 Participants
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
Saussy Method for Intraosseous Insertion
n=10 Participants
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
Standard Vidacare Method for Intraosseous Insertion
n=10 Participants
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.
Proximal Humerus Intraosseous (IO) Insertion Site Placement Score
1.9 units on a scale
Standard Deviation 1.4
1.7 units on a scale
Standard Deviation 1.3
1.4 units on a scale
Standard Deviation 1.4
2.0 units on a scale
Standard Deviation 1.4

PRIMARY outcome

Timeframe: within 10 minutes of the procedure

Population: 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.

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

Outcome measures
Measure
Campbell Method for Intraosseous Insertion
n=10 Participants
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
Davlantes Method for Intraosseous Insertion
n=9 Participants
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
Saussy Method for Intraosseous Insertion
n=10 Participants
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
Standard Vidacare Method for Intraosseous Insertion
n=10 Participants
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.
Time to Intraosseous (IO) Catheter Placement
116.6 seconds
Standard Deviation 17.0
136.5 seconds
Standard Deviation 18.8
121.0 seconds
Standard Deviation 42.1
126.3 seconds
Standard Deviation 29.1

Adverse Events

Campbell Method for Intraosseous Insertion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Davlantes Method for Intraosseous Insertion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Saussy Method for Intraosseous Insertion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Vidacare Method for Intraosseous Insertion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Subjects: Campbell and Saussy Methods

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Healthy Subjects: Davlantes and Standard Vidacare Methods

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Campbell Method for Intraosseous Insertion
n=10 participants at risk
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.
Davlantes Method for Intraosseous Insertion
n=10 participants at risk
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
Saussy Method for Intraosseous Insertion
n=10 participants at risk
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
Standard Vidacare Method for Intraosseous Insertion
n=10 participants at risk
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.
Healthy Subjects: Campbell and Saussy Methods
n=10 participants at risk
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 Subjects: Davlantes and Standard Vidacare Methods
n=10 participants at risk
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.
Musculoskeletal and connective tissue disorders
Soreness Pain in Arm
0.00%
0/10 • 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
0.00%
0/10 • 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
0.00%
0/10 • 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
0.00%
0/10 • 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
80.0%
8/10 • 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
90.0%
9/10 • 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
Musculoskeletal and connective tissue disorders
hematoma on the arm at the site of the intraosseous device insertion
0.00%
0/10 • 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
0.00%
0/10 • 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
0.00%
0/10 • 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
0.00%
0/10 • 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
10.0%
1/10 • 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
0.00%
0/10 • 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

Additional Information

Thomas Philbeck, PhD, Sr.Director Science and Clinical

Vidacare Corporation

Phone: 210-375-8500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place