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临床试验/NCT06486129
NCT06486129已完成不适用

Long-term Myocardial Effects of Noninvasive Ventilation in Patients With Obesity Hypoventilation Syndrome

Pavol Jozef Safarik University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Impedance cardiography measured cardiac output

研究概览

简要总结

Chronic effects of noninvasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS.

详细描述

Chronic effects of non- invasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS. Clinically stable patients with OHS referred to the tertiary centre for the initiation of long-term BiPAP therapy were consecutively enrolled in the study. At baseline, all participants underwent overnight cardiorespiratory polygraphy. BiPAP therapy using volume-targeted spontaneous/timed mode delivered via an oro-nasal mask was initiated. Beat-to-beat noninvasive monitoring by impedance cardiography was used to assess heart function at baseline and after 3 and 12 months of BiPAP use. Serum troponin 1, N-Terminal Pro-B-Type Natriuretic Peptide (NTProBNP), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6) were monitored. Potential risks and benefits comprise haemodynamic effects of NIV on cardiovascular parameters including cardiac output and stroke volume. The study started 06/2016 and enrolment was finalized in October 2018. The study was funded by grants from the Slovak Research and Development Agency under contract No. APVV-16-0158, and VEGA 1/0220/17 and 1/0393/22 of the Ministry of Education, Slovakia. The main investigator is Pavol Pobeha, MD, PhD, co author is Ivana Paranicova, MD, PhD and the corresponding author (study coordinator prof. Ruzena Tkacova, MD, PhD)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Clinically stable patients with OHS and chronic severe hypercapnia

排除标准

  • inability to provide written informed consent
  • neuromuscular diseases
  • chest wall diseases
  • metabolic diseases
  • acute respiratory tract infection
  • chronic obstructive pulmonary disease (COPD)
  • systolic LV failure as evidenced by LV ejection fraction<45% on echocardiography

结局指标

主要结局

Impedance cardiography measured cardiac output

时间窗: 12 months

Impedance cardiography measured cardiac output before and after effective treatment of respiratory failure

次要结局

  • Impedance cardiography measured stroke volume(12 months)

研究者

发起方
Pavol Jozef Safarik University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavol Pobeha

Pavol Pobeha, MD, PhD (Principal investigator)

Pavol Jozef Safarik University

研究点 (2)

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