The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in O2 saturation
研究概览
简要总结
This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.
详细描述
There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air
- •Ambulatory patients capable of performing 6 min walking test
- •Patients older than 18 years old.
排除标准
- •Patients with significant collagen disease causing Raynaud phenomenon.
- •Patients with hypothermia lower than 35 degrees Celsius
- •Patients with rest SpO2 values equal or lower than 80% on room air
- •Patients unable to perform PFTs
- •Patients unable to complete 6 min walking test without supp O
- •Patients unable to perform experimental deep breaths on CT scan
研究组 & 干预措施
Patients with rest O2 desaturation
Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values
干预措施: Deep breaths (Procedure)
结局指标
主要结局
Change in O2 saturation
时间窗: Lenght of experimental protocol: 6 minutes.
A Saturation change greater than 4% will be considered significant
次要结局
- Cardiac output (CO)(Lenght of experimental protocol: 6 minutes.)
- Vd/VT(Lenght of experimental protocol: 6 minutes.)
- CT recruitment(Lenght of experimental protocol: 6 minutes.)
研究者
Uriel Chavarria-Martinez
Professor of Internal Medicine Pulmonary and Critical Care
Universidad Autonoma de Nuevo Leon