NCT00725595Unknown不适用
Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Both ASV and Bilevel ventilation are effective in clinical treatment of CSR
研究概览
简要总结
The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
- •Subject is > 18 years old
- •Patients with known history of CSR. CSR symptoms may include the following:
- •sleep fragmentation as reported by patient or as witnessed by another person
- •night arousal after apneic episodes
- •reduced exercise capacity
- •daytime sleepiness
- •Expected to tolerate the ventilator therapy
排除标准
- •Baseline oxygen saturation < 90% on a stable FIO2)
- •Patient is currently enrolled in another clinical study which may confound the results of this study
- •Patient for whom informed consent cannot be obtained
- •Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
- •Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
- •Patients with severe COPD (per GOLD scale)
- •Patients with a history of myocardial infarction within the 6 months prior to the study
- •Patients with unstable angina
结局指标
主要结局
Both ASV and Bilevel ventilation are effective in clinical treatment of CSR
时间窗: three months
次要结局
- ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure(three months)
研究者
研究点 (1)
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