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不同通气模式对急性缺血性脑卒中后睡眠呼吸暂停患者早期预后的影响——一项前瞻性、开放标签、随机对照试验方案。

Effect of different ventilation modalities on the early prognosis of patients with sleep apnea after acute ischemic stroke---protocol for a prospective, open-label and randomised controlled trial.

机构信息

Department of Emergency Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.

出版信息

BMC Neurol. 2023 Jun 6;23(1):215. doi: 10.1186/s12883-023-03117-6.

Abstract

BACKGROUND

Sleep apnea is highly prevalent after acute ischemic stroke (AIS) and has increased stroke-related mortality and morbidity. The conventional sleep apnea treatment is continuous positive airway pressure (CPAP) ventilation. However, it is poorly tolerated by patients and is not used in all stroke patients. This protocol describes the impact of high-flow nasal cannula (HFNC) oxygen therapy compared to nasal continuous positive airway pressure (nCPAP) ventilation or usual care on the early prognosis of patients with sleep apnea after AIS.

METHODS

This randomised controlled study will be conducted in the intensive care unit of the Department of Neurology at the Wuhan Union Hospital. According to the study plan, 150 patients with sleep apnea after AIS will be recruited. All patients are randomly allocated in a 1:1:1 ratio to one of three groups: the nasal catheter group (standard oxygen group), the HFNC group, and the nCPAP group. Patients receive different types of ventilation after admission to the group, and their tolerance while using the different ventilation is recorded. Patients will be followed up by telephone three months after discharge, and stroke recovery is recorded. The primary outcomes were 28-day mortality, the incidence of pulmonary infection and endotracheal intubation.

DISCUSSION

This study analyses different ventilation modalities for early interventions in patients with sleep apnea after AIS. We will investigate whether nCPAP and HFNC reduce early mortality and endotracheal intubation rates and improve distant neurological recovery in patients.

TRIAL REGISTRATION

This trial was registered at ClinicalTrials.gov (NCT05323266; 25 March 2022).

摘要

背景

急性缺血性脑卒中(AIS)后睡眠呼吸暂停的发病率很高,增加了与中风相关的死亡率和发病率。传统的睡眠呼吸暂停治疗是持续气道正压通气(CPAP)。然而,患者耐受性差,并非所有中风患者都适用。本方案描述了高流量鼻导管(HFNC)氧疗与经鼻持续气道正压通气(nCPAP)通气或常规治疗相比,对 AIS 后睡眠呼吸暂停患者早期预后的影响。

方法

这项随机对照研究将在武汉协和医院神经内科重症监护室进行。根据研究计划,将招募 150 名 AIS 后睡眠呼吸暂停的患者。所有患者按照 1:1:1 的比例随机分配到三组之一:鼻导管组(标准吸氧组)、HFNC 组和 nCPAP 组。患者在分组后入住时接受不同类型的通气,记录他们对不同通气的耐受情况。患者在出院后三个月通过电话进行随访,并记录中风恢复情况。主要结局为 28 天死亡率、肺部感染和气管插管的发生率。

讨论

本研究分析了 AIS 后睡眠呼吸暂停患者早期干预的不同通气方式。我们将研究 nCPAP 和 HFNC 是否能降低早期死亡率和气管插管率,并改善患者的远隔神经恢复情况。

试验注册

本试验在 ClinicalTrials.gov 注册(NCT05323266;2022 年 3 月 25 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7b2/10243031/d34077f7dd86/12883_2023_3117_Fig1_HTML.jpg

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