Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

August 25, 2008 updated by: Nanjing Medical University
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The 1st Affiliated Hospitak of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Zhang Shijiang, MD
        • Principal Investigator:
          • Zhang Xilong, MD
        • Sub-Investigator:
          • Wang Hong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with both CSR and heart failure

Description

Inclusion Criteria:

  1. 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
  2. Subject is > 18 years old

  3. 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
  4. Expected to tolerate the ventilator therapy

Exclusion Criteria:

  1. Baseline oxygen saturation < 90% on a stable FIO2)
  2. Patient is currently enrolled in another clinical study which may confound the results of this study
  3. Patient for whom informed consent cannot be obtained
  4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
  5. 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)
  6. Patients with severe COPD (per GOLD scale)
  7. Patients with a history of myocardial infarction within the 6 months prior to the study
  8. Patients with unstable angina

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
E, 2, III
To treat CSR with ASV and Bilevel ventilators

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Both ASV and Bilevel ventilation are effective in clinical treatment of CSR
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 092801
  • 20070928
  • No 092801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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