NCT06147674尚未招募不适用
Evaluation of VQm Pulmonary Health Monitor™ on Pulmonary Health Parameters for Intensive Care Medicine
Rostrum Medical Innovations Inc.4 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Shunt fraction value
研究概览
简要总结
The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are:
- Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements.
- Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.
详细描述
This is a multi-site, international, prospective, non-blinded, non-randomized, observational study. This study aims to compare measurements from the VQm PHM™ to existing clinical measurements, assess safety of the device and determine effects that standard clinical events have on the VQm PHM™ measurements. This study does not include changes to clinical care based on measurements from the VQm PHM™. Each patient will serve as their own control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years old or above, at the time of the inclusion
- •Patient currently admitted in the ICU, who are indicated for cardiac output monitoring using a pulmonary artery catheter and who require pressure or volume controlled mechanical ventilation using an ETT
- •Provision of signed and dated informed consent form (ICF) by the patient or a trusted person
排除标准
- •Male or female under the age of 18 years old, at the time of screening
- •Patient under guardianship
- •Patient who requires tidal volumes of less than 250cc
- •Pregnancy
- •Patient whose care requires the use of an anesthetic conserving device
- •Patient whose care requires a closed-loop ventilator
- •Patient who is unable to tolerate a transient increase in inhaled CO2
- •Patient who is unable to tolerate a transient inhalation of N2O or is contraindicated to N2O use
结局指标
主要结局
Shunt fraction value
时间窗: Through study completion, an average of 12 months
Confirming the performance of non-invasive pulmonary health parameter shunt value found on the VQm PHM™ monitor when compared to available reference measurements
次要结局
- Pulmonary blood flow - trend(Through study completion, an average of 12 months)
- High pressure due to volume control (safety)(Through completion of study, up to 72 hours)
- Functional residual capacity - trend(Through study completion, an average of 12 months)
- Incident rate of adverse events, adverse events and treatment-emergent serious adverse events(Through completion of study, up to 72 hours)
- Safe range of nitrous oxide delivery (safety)(Through completion of study, up to 72 hours)
- Pulmonary blood flow - absolute value(Through study completion, an average of 12 months)
- Oxygen desaturation due to breathing circuit connectivity (safety)(Through completion of study, up to 72 horus)
- Functional residual capacity - absolute value(Through study completion, an average of 12 months)
- High volume due to pressure control (safety)(Through completion of study, up to 72 hours)
- Physiological dead space(Through study completion, an average of 12 months)
研究者
研究点 (4)
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