A prospective, single arm, multi-centric, post market clinical follow-up of CVP Manometer to explore safety and performance in Adult & Paediatric subjects in Indian population.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The Primary End Points of the study are as
研究概览
简要总结
This is a prospective, post marketing clinical follow-up of CVP Manometer to explore safety and performance in subjects who are expected to require continuous and intermittent monitoring of central venous pressure during short term infusion administration in ICU, CCU, OTs, casualty, emergency departments for continuous assessment of cardiac function, circulating blood volume & subjects response to the given treatment. Investigators and their team will be responsible for recruitment and ethical conduct of the follow-up. As per inclusion & exclusion criteria, subjects will be included in this follow-up. An informed consent / informed assent will be obtained from all subjects who are potential follow-up candidates prior to commencement of any follow-up related procedure.
All data will be collected in the follow-up specific Case Report Form.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Primary End Points of the study are as
时间窗: Device maximum use duration is not more than 5 days
1 For Central Venous Pressure monitoring
时间窗: Device maximum use duration is not more than 5 days
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
时间窗: Device maximum use duration is not more than 5 days
3 For continuous assessment of cardiac function circulating blood volume haemo-dynamics & patients response to the given treatment
时间窗: Device maximum use duration is not more than 5 days
4 Improving the Quality of life of the subject by achieving the intended purpose for Central Venous Pressure monitoring
时间窗: Device maximum use duration is not more than 5 days
次要结局
- 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)
研究者
Dr Dheeraj Singh
Atharva Multispecialty Hospital and Research Centre