Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Central Venous Catheter Kit-(1) Single Lumen: Catheter OD 5 Fr (1.70mm), Length 20cm, Catheter ID 16GA.
(2) Double Lumen:
(a) Catheter OD 5 Fr (1.70 mm), Length 8 cm, Catheter ID 18
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females (Adult & Paediatric) who are expected to require Central Venous Catheterization for provision of short term intravenous infusion of parenteral fluids, medication, nutrition, chemotherapy, blood transfusion, sampling, etc. 2. Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics, parent of child / LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child). 3. The subject who is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics, parent of child / LAR (Legally Acceptable Representative) who is willing and able to comply with the requirement of the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subject who is present with medical emergency, where treatment is more priority than the informed consent / informed assent process. 2. Subject with severe conditions like bleeding disorders, coagulopathy, infection at the site, distorted local anatomy etc. 3. Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Paediatrics, parent of child / LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc. 4. Any known allergy with any of the material of the Central Venous Catheter Kit and its component(s). 5. Other conditions, which in the opinion of investigators make the patient unsuitable for enrollment or could, interfere with his / her participation in, and completion of the clinical investigation plan / protocol. 6. Subject who is pregnant or breastfeeding. 7. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 8. Participation in another research study involving an active investigation within 30 days prior to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful completion of device intended performance for intravenous infusion of parenteral fluids, medication, nutrition, chemotherapy, blood transfusion, blood sampling, etc. in the target population.Timepoint: Short Term Use (Maximum 7-10 Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed