Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Correlation between POMCO2
研究概览
简要总结
The objective of this non-significant risk (NSR) study is to evaluate the safety and efficacy of the MicroTrend System by correlating POMCO2 data with relevant clinical metrics including arterial pressure and heart rate.
详细描述
This is a prospective, single-center, non-randomized, non-significant risk (NSR) study evaluating the safety and efficacy of the MicroTrend System, which is indicated for monitoring oral mucosal carbon dioxide pressure (POMCO2) in hospital patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adult (age 22 years and older) in the critical care unit
- •Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable)
- •Willing and physically able to comply with the study protocol and procedures
排除标准
- •Evidence of intra- or peri-oral, buccal, or gingival disease or trauma to the face or mouth that may interfere with MicroTrend System that is deemed clinically significant by the investigator
- •Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct
- •Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
结局指标
主要结局
Correlation between POMCO2
时间窗: 4-6 hours
Assessed by the MicroTrend System and the relevant clinical metrics of mean arterial pressure and heart rate. Statistically significant correlations (defined as p \< 0.05) will be deemed success for this purpose, with adjustment for multiplicity by the Hochberg-Holm method
次要结局
未报告次要终点