To explore the safety and performance of Pressure Monitoring Line in Adult & Paediatric subjects in Indian population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/10/059352
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Males and Females (Adult & Paediatric) who are expected to require Pressure Monitoring Line for administration of intravenous fluids and for pressure monitoring.
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.
1.Subject who present with medical emergency, where treatment is more priority than the informed consent/informed assent process.
2.If Subject will be given light sensitive medications, corrosive medications, highly osmolality medications, not suitable for administration with syringe pump, 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 Pressure Monitoring Line and its component(s).
5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with the participation in, and completion of the protocol.
6.Subject who is pregnant or breast feeding.
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
- Secondary Outcome Measures
Name Time Method