To explore the safety and performance of Pressure Monitoring Line in Adult & Paediatric subjects in Indian population.

A prospective, single arm, multi-centric, post market clinical follow-up of Pressure Monitoring Line (for administration of intravenous fluids and for pressure monitoring) to explore its safety and performance in Adult & Paediatric subjects in Indian population. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/059352

Enrollment

100

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: (1)PM-O-Line GS-3036 (a)PM-O-Line Red GS-3036 (b)PM-O-Line Blue GS-3036 (c)PM-O-Line Yellow GS-3036 (2)PM-O-Line Spiral GS-3036S (3)PM-O-Line 3-way Stop Cock GS-3036SC (4)Hi-Line Plain

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Administration of intravenous fluids in clinical care for use with syringe pump. 2. Accessory to arterial line for invasive pressure monitoring. 3. Duration of use. Timepoint: Device Maximum Use duration is 5 days.	—

Secondary

Measure	Time frame
1. Material Compatibility with the IV Fluids / medicines. 2. Secure Fitment with connection / combination devices. 3. Compatible operations with syringe pump. 4. Kink Resistant Tubing. Timepoint: Devices maximum use duration is 5 days.	—

Countries

India

Contacts

Public ContactDr Anoop Batra

Romsons Group Private Limited

cta1@romsons.com9971256314

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026