Prospective Non-Interventional Study Evaluating Non-invasive Measurements of Pulmonary Blood Flow, Functional Residual Capacity, Shunt Fraction Index and Airway Dead Space Measured With the VQm PHM™ to Clinical Gold Standards
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of pulmonary function parameters to known clinical standards
研究概览
简要总结
This is a prospective, observational study to assess agreement of pulmonary health parameters measured by a new non-invasive physiologic monitor, the VQm pulmonary health monitor (PHM)™ with clinical gold standards.
详细描述
The specific aim of this study is to evaluate the intermittent non-invasive measurements of pulmonary function: pulmonary blood flow (PBF), functional residual capacity (FRC), shunt fraction index (Qsi) and airway dead space measured by the VQm PHM™ compared to known clinical standards. PBF will be compared to continuous and intermittent bolus thermodilution cardiac output as measured through a Swan-Ganz catheter. FRC will be compared to an FRC measurement provided by a standard nitrogen washout method. Qsi will be compared to shunt fraction calculated through mixed venous and arterial blood gas values (VBGs/ABGs). Airway dead space will be compared to an airway dead space measurement provided by a ventilator.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 18 years
- •Scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia without the use of inhalation anesthetics
- •Surgical procedure that requires pressure-controlled positive pressure ventilation using an endotracheal tube
- •Surgical procedure that requires the use of intra-arterial pressure monitoring and/or a Swan-Ganz catheter for the monitoring of continuous cardiac output
排除标准
- •Patients who require ventilation tidal volumes less than 250cc
- •Age less than 18 years
- •Pregnancy
- •Prisoners
- •Surgical procedure which requires carbon dioxide (CO2) insufflation
- •Unable to tolerate a transient increase in inhaled CO2
- •Unable to tolerate a transient increase in inhaled nitrous oxide (N2O) or use of N2O is contraindicated
- •Patients who require a high fraction of inspired oxygen (FiO2) (>70%) to maintain a hemoglobin saturation (SpO2>98%)
- •Women, minorities or non-English speaking subjects will not be excluded
结局指标
主要结局
Comparison of pulmonary function parameters to known clinical standards
时间窗: Through study completion, an average of 12 months
Assess agreement between measurements from VQm PHM™ to clinical gold standards
次要结局
未报告次要终点