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Adaptive Servo Ventilation (ASV) in Heart Failure

NCT02440971 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2018-07-26

No results posted yet for this study

Summary

Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. SDB is however, treatable with the use of non invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The aim of the study is to observe and investigate the potential role of ASV in the management of heart failure.

Patients that agree to participate in this study will be requested to use an ASV ventilator device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is approximately the size of a large shoe box, which can be placed at the side of the bed, with tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows positive air pressure as determined by the device itself as it constantly monitors the patients breathing throughout the night. During this study, the patients breathing patterns will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a SleepMinder will sit on the patients bedside locker as another form of monitoring of their sleep patterns. Study staff will monitor the patient and give them frequent support, and they will also be asked questions regarding their experiences with this equipment and any symptoms they may have over this time. They will be followed up regarding this study at the same time as their follow-up requirements for their heart failure. This study will be conducted in total over 3 months.

Conditions

  • Acute Decompensated Heart Failure
  • Sleep Disordered Breathing

Interventions

DEVICE

S9-Autoset CS-A

The S9-Autoset CS-A is an adaptive servo-ventilation (ASV) machine. It adjusts the level of inspiratory support automatically in response to the patient's respiratory effort. Inspiratory support is increased in the presence of hypoventilation and decreased in the presence of hyperventilation.

Sponsors & Collaborators

  • ResMed

    collaborator INDUSTRY

  • St Vincent's University Hospital, Ireland

    lead OTHER

Principal Investigators

  • Kenneth M McDonald, MD · St Vincent's University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2019-05-31
Completion
2019-09-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440971 on ClinicalTrials.gov