N/A
Completed N=24
Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
Intraosseous Vascular Access
Source: ClinicalTrials.gov NCT01853215 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Occurrences of Extravasation During Infusion — 2 participants
Summary
This study is being done to evaluate intraosseous vascular access through the sternum.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrences of Extravasation During Infusion |
2 | — |
| SECONDARY Stability of Locator |
4.04 | — |
| SECONDARY Stability of Catheter Hub |
4.35 | — |
| SECONDARY Adhesion Strips |
3.83 | — |
| SECONDARY Gravity Flow Rates |
1130.44 | — |
| SECONDARY 100 Millimeters of Mercury (mmHg) Infusion Flow Rates |
3373.91 | — |
| SECONDARY 200 Millimeters of Mercury (mmHg) Infusion Flow Rates |
4619.05 | — |
| SECONDARY 300 Millimeters of Mercury (mmHg) Infusion Flow Rates |
5327.27 | — |
Eligibility Criteria
Inclusion Criteria
- 21 years of age or older;
- healthy adult subjects
Exclusion Criteria
- Weight < 45kg;
- BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
- Imprisoned subjects;
- pregnant subjects;
- prior sternotomy;
- cognitively impaired subjects;
- fracture in target bone, or significant trauma to the site;
- excessive tissue and/or absence of adequate anatomical landmarks in target bone;
- infection in target area;
- IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
- current use of anti-coagulants;
- previous adverse reaction to Lidocaine;
- current cardiac condition requiring pacemaker or anti-arrhythmic drugs
- previous adverse reaction to contrast dye
- Allergy to any food and drug
- History of impaired renal function
- History of impaired hepatic function
- History of cardiac disease
- History of pheochromocytoma
Data sourced from ClinicalTrials.gov (NCT01853215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.