Status:
UNKNOWN
Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
Lead Sponsor:
Nanjing Medical University
Conditions:
Heart Failure
Sleep Apnea
Eligibility:
All Genders
18-70 years
Brief Summary
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 characteriz...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00725595
Start Date
August 1 2008
End Date
December 1 2008
Last Update
August 26 2008
Active Locations (1)
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1
The 1st Affiliated Hospitak of Nanjing Medical University
Nanjing, Jiangsu, China, 210029