Health Condition 1: - Health Condition 2: Y999- Unspecified external cause status
Conditions
Interventions
Intervention1: Ozyn-Dâ?¢ is a novel Intraosseous (IO): The Ozyn-Dâ?¢ intraosseous device is primarily used during medical emergencies as an alternative to unsuccessful or difficult intravenous access
Sponsors
RCupe Lifesciences Private Limited
BIRAC Grant
Eligibility
Inclusion criteria
Inclusion criteria: Following subjects will be included in the study: 1. Adult male or female subjects greater than or equal to 18 years of age. 2. Hospitalized in the ward requiring vascular access, in whom attempts to secure IV access have failed after performing 3 attempts.3. Must be able to comply with the study related procedures. 4. Subject or the legally accepted representative willing to provide written Informed Consent before any study-specific tests or procedures are performed.
Exclusion criteria
Exclusion criteria: Following subjects will be excluded from the study: 1. Patients below 18 years. 2. Areas of cellulitis, burns, or infection at the target site of IO access. 3. Pregnant or lactating women. 4. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days. 5. Known or suspected immuno-compromised subjects 6. Known/suspected case of bleeding &/or coagulation disorders 7. Known/suspected case of multiple myeloma, metastatic diseases. 8. Known/suspected case of pathophysiological conditions at skin, bone, or tissue at or near target site 9. Known/suspected patients with intracardiac shunts. 10. Patients with known/suspected fracture or vascular injury distal or proximal to the target site. 11. Any condition not found appropriate as per the Investigator discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Ozyn-Dâ?¢ will be assessed by: i. Frequency, incidence and severity of device, patient and procedure related complications and other adverse events. ii. Evidence of problem-free infusion of fluids without softtissue swelling Adverse events will be assessed on a continuous basis from the procedure through the study completionTimepoint: The observations will be made right after insertion, at 30 min, 1 hour, 2 hours and 4 hours post insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of Ozyn-Dâ?¢ as determined by problem free infusion of at least 50 mL of fluids through the IO route without any adverse eventTimepoint: The observations will be made right after insertion, at 30 min, 1 hour, 2 hours and 4 hours post insertion | — |
Countries
India
Contacts
Public ContactJayant Sitaram Karve
M.S Ramaiah Medical College
Outcome results
None listed