The First Affiliated Hospital of Nanjing Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- nocturnal fluid shift, as determined by change in leg fluid volume
研究概览
简要总结
Fluid retention in the legs due to chronic heart failure (CHF) during the daytime may redistribute to neck when with supine positioning at night. A portion of the shifted fluid accumulates in the neck, and narrows the upper airway, predisposing the patient to obstructive sleep apnea (OSA) and central sleep apnea (CSA). However, the mechanism of overnight fluid shift on OSA and CSA remains unclear. The investigators pre-experiment demonstrated there may be a different mechanism of overnight fluid shift on OSA and CSA. The accumulation of water content in neck soft tissue increases neck circumference and leads to pharyngeal resistance, upper airway collapse and causes OSA. The effect of nocturnal fluid shift on CSA may be because of increasing of chemosensitivity (fluctuation of PaCO2), circulation delay and hemodynamic disordered. This study is aimed to explore the different mechanism of overnight fluid shift on OSA and CSA by comparing the changes of upper airway (inside diameter, water content, and pharyngeal resistance), PaCO2, circulation delay (lung-to-finger circulation time) and hemodynamic (loop gain).
详细描述
Methods:
Between June 2015 and December 2017, 180 patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease (in Cardiology Department and Cardiothoracic Surgery Department of the First Affiliated Hospital of Nanjing Medical University), were screened for sleep apnea by polysomnography (PSG). Of them, 20 obstructive sleep apnea (OSA) and 20 central sleep apnea (CSA) were enrolled. Clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test (6MWT) were recorded.
The fluid index, head and neck CT and pharyngeal resistance were tested at 20:00. Then a full night PSG and percutaneous PaCO2 were performed. The fluid index, head and neck CT and pharyngeal resistance were repeated at 6:00 after PSG.
The volume of fluid shift from legs to head and neck,inside diameter of the upper airway, and water content of neck soft tissue were calculated. The lung-to-finger circulation time and loop gain were measured.
- Mechanism of overnight fluid shift on OSA:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic heart failure caused by rheumatic heart disease, cardiomyopathy and coronary heart disease
- •aged between 18 to 70 years
- •with symptomatic stable heart failure, New York Heart Association (NYHA) class >= II despite optimal drug therapy
- •patients combined with sleep apnea (apnea-hypopnea index >=10/h) according to the results of polysomnograph.
排除标准
- •history of stroke or clinical signs of peripheral or central nervous system disorders
- •chronic obstructive pulmonary disease or history of asthma
- •enrolment in another clinical study
结局指标
主要结局
nocturnal fluid shift, as determined by change in leg fluid volume
时间窗: up to 24 months
Nocturnal fluid shift was measured for 40 enrolled participants.
pharyngeal resistance,as the change from baseline in pharyngeal air-flow resistance
时间窗: up to 24 months
Pharyngeal resistance was measured for 40 enrolled participants.
Lung to Finger Circulation Time
时间窗: up to 24 months
Lung to Finger Circulation Time was measured for 40 enrolled participants.
Loop Gain
时间窗: up to 24 months
Loop Gain was measured for 40 enrolled participants
apnea-hypopnea index, as the severity of sleep apnea.
时间窗: up to 24 months
Apnea-hypopnea index was measured for 40 enrolled participants.
次要结局
未报告次要终点
研究者
Ning Ding
Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University
Nanjing Medical University