Noninvasive Monitor of Vascular Volume Fluid Shifts
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in phonographic characteristics - amplitude
研究概览
简要总结
Blood volume measurements are a critical step in the emergency care of trauma patients. The typical approach to this is to rely on historical information, physical examination and metrics such as heart rate. There is currently no good real-time measure to track blood volume. This study investigates the use of phonocardiography (listening to the sounds made by the heart) to track changes in central blood volume.
详细描述
Blood draw subjects:
Participation in this study group may last up to 60 minutes. Participants will begin with a brief medical exam to determine eligibility. This will include a review of any history of cardiovascular disease and of medications. Prior to a scheduled blood draw, eligible participates will have physiological measurements taken, which may include phonocardiographic measurements, cardiac output, plethysmography (volume changes), multifrequency bioimpedance, thoracic impedance, heart rate, blood pressure, pulse oximetry, continuous non-invasive hematocrit measurement, and respiration. The phonocardiographic measurements may be taken with both a commercial and a custom-built device. These are all non-invasive measurements. After 15 minutes of baseline measurements, a blood draw will proceed normally while the physiological measurements continue. After the participant is finished donating blood, the participant will be asked to stay in place for an additional 15 minutes to continue to collect physiological data. Participants are asked not to eat or drink during the 15 minutes as this will provide better data collection. The information collected as data for this study includes: information about medical history, body measurements, and physiological measurements.
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
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In generally good health
- •Free of systemic diseases
- •No contraindications to LBNP exposure.
- •No prior history of cardiovascular disease
- •Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg).
排除标准
- •Individuals who, after lying supine for five minutes, show a greater than 10 mm Hg drop in systolic pressure or a greater than 20 beats/minute increase in heart rate with standing during pre-enrollment evaluation
- •Blood draw participants:
- •Inclusion Criteria:
- •In generally good health
- •Free of systemic diseases
- •No current or prior history of cardiovascular disease or cardiovascular reactive drugs
- •Blood donors through the DHMC blood donation center
- •Healthy volunteers
- •People who are taking part in another study where about 500 ml of blood is being drawn
- •Therapeutic phlebotomy patients (hemochromatosis or polycythemia vera patients)
- •Exclusion Criteria:
- •Pregnancy
结局指标
主要结局
Change in phonographic characteristics - amplitude
时间窗: Through study completion; 3 hours
Size of cardiac systolic and diastolic heart tones
Change in cardiac cycle time intervals
时间窗: Through study completion; 3 hours
Cardiac systolic and diastolic times
Change in phonographic characteristics - frequency
时间窗: Through study completion; 3 hours
Frequency content of cardiac tones
次要结局
未报告次要终点
研究者
James C. Leiter
Principal Investigator, Professor of Molecular and Systems Biology
Dartmouth-Hitchcock Medical Center