Effect of Different Ventilation Modalities on the Early Prognosis of Patients With Sleep Apnea After Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Tracheal Intubation Rate
研究概览
简要总结
Acute ischemic stroke is the second leading cause of death and disability, and it is also one of the main reasons for the high cost of health care. The major risk factors for stroke are hypertension, atrial fibrillation, and smoking, which are the main intervention targets for primary stroke prevention. Although these recognized risk factors have been adequately treated, there are also significant differences in stroke incidence and outcome in the population. Sleep apnea is a common complication of acute ischemic stroke, characterized by upper airway obstruction and obstructive sleep apnea.
Nowadays, more studies are currently investigating CPAP to promote long-term neurological recovery, improve the ability to perform activities of daily living, and reduce the recurrence of cardiovascular disease in stroke patients. However, 25%-50% of patients with sleep apnea will refuse or be intolerant of ventilation with CPAP. High-flow nasal cannula (HFNC) therapy is a revolutionary non-invasive respiratory support option that is widely used in NICU worldwide. This trial aims to investigate the value of different ventilation methods in reducing the rate of pulmonary infections and tracheal intubation in stroke patients.
This trial is a prospective randomized cohort study, collecting patients with acute ischemic stroke in the intensive care unit of the Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from 2022.05.01 to 2023.01.31. Participants who met the inclusion criteria were subjected to polysomnography on the first day of admission, and those diagnosed with sleep apnea according to the diagnostic criteria for sleep apnea were randomly grouped. Participants were given different forms of oxygen therapy, such as usual care therapy (nasal cannula and facemask), nasal continuous positive airway pressure (nCPAP), and HFNC oxygen therapy. After one week of observation, the investigators evaluated whether there were differences in the rate of tracheal intubation and pulmonary infection between the groups, as well as the length of hospitalization, hospital costs, and neurological recovery. All enrolled patients were followed up 1 month after discharge.
详细描述
Study population:
Participants with acute ischemic stroke in the intensive care unit of the Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology were selected, with stroke onset within one week.
Diagnostic criteria:
Presence of clear clinical manifestations of acute ischemic stroke and clear cerebral infarct lesions on CT and MRI.
Content and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical outcome assessors in this study were blinded, and blinding was not possible for participants, investigators and care providers.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Clinical diagnosis of acute ischemic stroke and sleep apnea (AHI≥5/hour)
- •Definite cerebral infarct lesions on CT and MRI
- •National Institutes of Health Stroke Score (NIHSS) baseline score of 2-20
- •State of consciousness (Glasgow Coma Score of ≥9)
- •Semi-quantitative cough strength score of ≥2.
排除标准
- •Pre-existing obstructive sleep apnea
- •Suspected sleep disorders other than sleep apnea (e.g., episodic sleeping sickness)
- •Respiratory distress requiring mechanical ventilation
- •Oxygen-dependent chronic obstructive pulmonary disease
- •Pregnancy
- •Intracranial hemorrhage
- •Inability to use a nasal mask or mask (e.g., facial trauma)
- •Patients who died within 24 h of admission
- •History of other neurological disorders such as Parkinson's disease, neuro infection, neuromuscular disease patients
- •Hospice care or comfort measures only
- •Inability to provide informed consent
- •Inability to provide valid information
- •Suicidal ideation.
结局指标
主要结局
Tracheal Intubation Rate
时间窗: one week
To observe the change of tracheal intubation rate between different groups after 1 week of ventilation in patients with acute ischemic stroke using different ventilation methods after admission.
Pulmonary Infection Status
时间窗: one week
To observe the change in the rate of pulmonary infection between different groups after 1 week of ventilation in patients with acute ischemic stroke using different ventilation methods after admission
28-day mortality rate
时间窗: 28 days
Patients with acute ischemic stroke were treated with different modes of ventilation after admission to observe whether there was any difference in 28-day mortality among different groups of patients.
次要结局
- Barthel Index(1 month)
- National Institute of Health stroke scale (NIHSS)(one week)
- Neurological Recovery (modified Rankin scale)(1 month)
- Sleep Apnea Symptoms(one week)
- Time of Hospitalization(From date of randomization until the date of death from any cause or discharge, whichever came first, assessed up to 3 months.)
- Cost of Hospitalization(From date of randomization until the date of death from any cause or discharge, whichever came first, assessed up to 3 months.)
研究者
Wang xiaorong
Internal medicine physician
Wuhan Union Hospital, China