NCT05677984已完成不适用
Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study
Southeast University, China1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2023年1月11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
- 409
- 试验地点
- 1
- 主要终点
- 28-day intubation rate
研究概览
简要总结
Awaken prone positioning (APP) ventilation has been widely accepted as a standard regimen in the management of COVID-19 patients. Physiological studies have proved ventilation/perfusion improvement during APP in COVID-19, which was associated improved oxygenation. However, the optimal duration for APP was not yet demonstrated. In this study, we aimed at the prolonged APP to see whether this could improve patients outcomes.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18-yr to 85-yr
- •Severe COVID-19 pneumonia (with typical radiographic alternations) and non-intubated patients.
- •SpO2 <= 93% with ambient air at rest.
- •PaO2/FiO2 <= 300 mmHg
排除标准
- •Definite intolerance to APP (e.g. pregnancy, extremity deformity, recent fracture, open thoracic or abdominal surgery, pace-maker implant in recent 48-hr, spine stability, pelvis or facial fractures, predicted difficult airway)
- •morbidity obesity, BMI > 40
- •consciousness disorder (GCS < 13), delirium dementia
- •hemodynamic instability (with norepinephrine >20 ug/min )
- •NYHA Grade III or IV
- •Severe hemoptysis
- •long term home oxygenation of CPAP
- •Refuse invasive mechanical ventilation (DNI DNR)
结局指标
主要结局
28-day intubation rate
时间窗: follow-up till 28-day
whether the patients' were intubated
次要结局
- mortality (ICU hospital) length of ICU (hospital) stay(follow-up during the ICU/hospital stay, up to 28 days)
- APP duration/days(follow-up till APP ended, daily duration of APP also recoreded, up to 7 days)
- Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication(follow-up till 28-day)
研究者
Ling Liu
Professor
Southeast University, China
研究点 (1)
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