An interventional study of BiPAP ventilation, auto-trilevel ventilation in Overlap Syndrome, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment
Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are two diseases that often coexist and are called overlap syndrome(OS). Compared to single OSAS, OS patients are more susceptible to serious hypoxia and hypercapnia especially during sleep, and are much more likely to result in pulmonary hypertension and cor-pulmonal.
With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia simultaneously. The overall purpose of this study is to compare the curative effects between fixed BiPAP and auto-trilevel ventilations on OS patients.
The contradiction in treatment for overlap syndrome is how to improve hypercapnia because of narrower difference between inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), and meanwhile to eliminate apnea and popnea events which may easily occur at the end of expiration For ordinary Bipap ventilator. If the IPAP is set to higher, the patients may feel discomfort, if the pressure difference between IPAP and EPAP is too narrow or the expiratory positive airway pressure (EPAP) too high, hypercapnia may occur. If the EPAP is too low, redusual apnea and hypopnea event may become common.
Auto-trilevel ventilation, with a lower airway pressure at the beginning of expiration to prevent hypercapnia and a higher airway pressure at the end of expiration to prevent residual apnea events, should be able to provide a novel ventilation mode with a higher efficacy and lower average airway pressure for overlap syndrome. To prove the hypothesis, comparison is made between ordinary BiPAP and auto-Trilevel ventilation modes during treatment for patients with overlap syndrome.
In this study, the investigators compare the changes of related indexes including apnea hypopnea index、minimal pulse oxygen saturation、arousal index, sleep quality,PaCO2 and sleepiness scores) before and on treatment. Meanwhile, curative effects will be compared between BiPAP and auto-Trilevel ventilation modes. The investigators will analyze the changes and then confirm our hypothesis.
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This study's enrollment of 17 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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The comparison of the curative effect on OS between BiPAP and auto-trilevel ventilations
Device: BiPAP ventilation, auto-trilevel ventilation
Noninvasive ventilation including fixed BiPAP ventilation and auto-trilevel ventilation. Using the same IPAP, treatment include one night with BiPAP ventilation mode 1, one night with BiPAP ventilation mode 2 and one night with auto-trilevel ventilation mode. Each treatment last 8 hours for each night.
Also known as: bi-level postive airway preesure ventilation;, auto-trilevel ventilation
different effects between BiPAP and auto-Trilevel ventilators on OS
The overall purpose of this study is to determine the effects of auto-Trilevel ventilation on patients with overlap syndrome by comparison with BiPAP ventilation. The following parameters are compared such as apnea hypopnea index, lowest SPO2, arousal index, sleep efficiency, PaCO2, daytime sleepiness and so on.
Time frame: Participants will be observed for the duration of hospital stay, an expected average of 1 weeks
The record gives a start of Aug 2011, a primary completion of Oct 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →