Clinical Respiratory Evaluation Using Spectroscopy Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measure and demonstrate the relationship between RMBF and WOB
研究概览
简要总结
Respiratory muscles (the muscles used to breathe) need more blood (and oxygen) when their workload increases. It is difficult to measure respiratory muscle blood flow (RMBF) without invasive techniques. We will evaluate a new, much less invasive technique to measure RMBF in 2 groups: Healthy Volunteers and Critically Ill patients on breathing machines. The purpose of this study is to determine the accuracy of this new monitoring technique called Near Infrared Spectroscopy Utilizing Indocyanine Green Dye when compared with traditional measurements. The information gained from this study will help us to provide better care to patients with severe lung problems.
详细描述
PURPOSE To demonstrate the relationship between Respiratory Muscle Blood Flow and Work of Breathing using Near Infrared Spectroscopy utilizing Indocyanine Green Dye NIRS-ICG.
HYPOTHESIS AND OBJECTIVES
HYPOTHESIS #1: In subjects with normal respiratory muscle function (healthy volunteers) RMBF as measured by the NIRS-ICG technique will vary directly with work of breathing (WOB) as measured by changes in transpulmonary pressure gradients and as measured by Esophageal and Surface EMG.
Objective #1: To measure and demonstrate the relationship between RMBF and WOB/EMG in healthy volunteers simulating abnormal pulmonary resistance.
Objective #2: To measure and demonstrate the relationship between RMBF and WOB in healthy volunteers simulating abnormal pulmonary compliance.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •19 years of age or older
- •Informed Consent Obtained
- •No history of cardiopulmonary disease
- •No history of smoking
- •Critically Ill
- •19 years of age or older
- •Informed Consent Obtained
- •Total pulmonary system resistance (as measured through the mechanical ventilator circuit) of 2-8 cmH20/L/second OR Total pulmonary system static compliance (as measured through the mechanical ventilator circuit) of 20-60 ml/cmH20
- •Exclusion Criteria for all studies:
- •Esophageal lesions or esophageal surgery within the last 6 months
- •Morbid obesity - defined as a Body Mass Index (BMI) > 40
- •Allergy to any of the following: sulpha medications, penicillin, contrast dye, or iodine
排除标准
- 未提供
结局指标
主要结局
Measure and demonstrate the relationship between RMBF and WOB
时间窗: 3 hours
To measure and demonstrate the relationship between RMBF and WOB in healthy volunteers simulating abnormal pulmonary resistance and compliance AND in critically ill subjects with abnormal respiratory muscle function (weaning from mechanical ventilation after exacerbations of COPD or ARDS).
次要结局
- Demonstrate differences in RMBF-WOB between 2 cohorts(3 hours)