To explore safety and performance of Bi-Valve (Three-way Stop Cock) used with infusion line and pressure monitoring in Indian Population.
- Conditions
- Health Condition 1: Z69-Z76- Persons encountering health services in other circumstances
- Registration Number
- CTRI/2021/04/032495
- Lead Sponsor
- Romsons Scientific and Surgical Industries Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.
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 follow-up.
1.Subject who present with medical emergency, where treatment is more priority than the informed consent process.
2.Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.
3.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
4.Any known allergy of material of Three-way stop cock and its component.
5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful completion of performance timelineTimepoint: Not Beyond 5 days
- Secondary Outcome Measures
Name Time Method ATimepoint: NA