Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: CVP Manometer (GS-3008): Device maximum use duration is 5 days.
Control Intervention1: NA: NA
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adult & Paediatric who are expected to require Central Venous Pressure monitoring assessment & monitoring of hemodynamics fluid status etc in critical medical conditions 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 Subject with severe conditions like Obstructed Vein Stenosis of the vein severe coagulopathy Traumatized site 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 CVP Manometer and its components 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 clinical investigation plan or 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 |
|---|---|
| The Primary End Points of the study are as 1 For Central Venous Pressure monitoring 2 Facilitating continuous and intermittent monitoring of central venous pressure during short term infusion administration in ICU CCU OTs and casualty to monitoring fluid status in critical medical conditions 3 For continuous assessment of cardiac function circulating blood volume haemo-dynamics & patients response to the given treatment 4 Improving the Quality of life of the subject by achieving the intended purpose for Central Venous Pressure monitoringTimepoint: Device maximum use duration is not more than 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Points of the study are as 1 Durability Sustainability of device its fitment to the accessories with standard combination or connection devices required during the period of use 2 Materials Compatibility with the body fluidsTimepoint: Device maximum use duration is not more than 5 days | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed