跳至主要内容
临床试验/NCT00725595
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

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

发起方
Nanjing Medical University
申办方类型
Other

研究点 (1)

Loading locations...

相似试验