CTRI/2020/01/022807
Completed
Phase 4
A prospective, single arm, post market clinical follow-up study of Endotracheal Tube to evaluate safety and performance in Indian population.
Romsons Scientific Surgical Industries Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Romsons Scientific Surgical Industries Pvt Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and Females above 18 year expected to require mechanical ventilation.
- •2\. Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process.
- •3\. The subject is willing and able to comply with the requirement of the study protocol.
Exclusion Criteria
- •1\. Subject who present with medical emergency, where treatment is more priority than the informed consent process.
- •2\. Subject, who cannot provide informed consent in general such as unconscious, mentally challenged patient, vulnerable subject etc.
- •3\. Allergy with any of the material of Endotracheal Tube and its component.
- •4\. Subject who is pregnant or breastfeeding.
- •5\. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
- •6\. Participation in another research study involving an investigational agent within 30 days prior to consent.
Outcomes
Primary Outcomes
Not specified
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