Pulmonary Imaging-based Postural Ventilation in Patients With Severe COVID-19 - a Prospective, Non-randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
COVID-19 remains a widespread global epidemic, increasing morbidity, mortality, healthcare resource consumption, and socio-economic burden on patients worldwide. The onset of COVID-19 ranges from mild, self-limiting respiratory disease to severe progressive pneumonia, mainly acute respiratory distress syndrome (ARDS), with critically ill patients requiring admission to the intensive care unit (ICU).
Prone positioning has been shown to improve oxygenation and reduce complications and mortality in patients with severe ARDS. Prone position increases functional residual volume and chest wall elasticity, reduces dorsal segment edema in both lower lungs, facilitates uniform ventilation distribution, improves V/Q ratio, reduces alveolar shunts, and aids secretion drainage. In clinical practice, the prone position is mainly used for patients with diffuse bilateral lung lesions. However, it is less effective in unilateral or predominantly upper lung patients. Moreover, some patients are unable to tolerate prone ventilation. Therefore, we construct an individualized approach to postural oxygen therapy by guiding the patient's position based on the pulmonary imaging information.
A study on the optimal ventilation position for patients with severe COVID-19 will be conducted at the Department of Respiratory and Critical Care Medicine, Wuhan Union Hospital. The investigators enrolled adult patients (without endotracheal intubation) diagnosed with severe COVID-19 requiring oxygen therapy from 2023.01.10 to 2024.01.10. Patients were grouped into control and intervention groups according to current treatment protocol and pulmonary imaging combined with patients' wishes and degree of postural tolerance. Patients in the intervention group were ventilated in different positions according to pulmonary imaging, including prone, left/right lateral, supine, semi-recumbent, and seated. In contrast, patients in the control group were ventilated comfortably according to the treatment principles and their wishes. The primary observation was 28-day mortality. Secondary observations were oxygenation index (PaO2/FiO2) before and after a position change, endotracheal intubation rate, duration of respiratory support, length of hospital stay, and comfort in position.
详细描述
Study population:
Adult patients with severe COVID-19 requiring oxygen therapy who were not endotracheally intubated at the Department of Respiratory and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology were selected.
Diagnostic Criteria:
Diagnostic criteria for severe COVID-19: A diagnosis of severe COVID-19 is made when any of the following criteria are met.
- Presence of shortness of breath with an RR ≥ 30 beats/min.
- Finger oxygen saturation ≤93% on air inhalation at rest.
- Oxygenation index (arterial partial pressure of oxygen/oxygen concentration) ≤ 300 mmHg (1 mmHg = 0.133 kPa), or arterial partial pressure of oxygen ≤ 60 mmHg when breathing air at rest.
- Progressive worsening of clinical symptoms and pulmonary imaging showing the significant progression of >50% of the lesion within 24 to 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admitted with a confirmed diagnosis of COVID-19 severe pneumonia
- •Patients without endotracheal intubation requiring high flow nasal cannula, non-invasive ventilator, mask, nasal cannula assisted ventilation
- •Signed informed consent
排除标准
- •Hemodynamic instability
- •Unstable spinal fractures
- •Unstable pelvic or long bone fractures
- •Open abdominal wounds
- •Late pregnancy
- •Increased intracranial pressure due to a lesion in the head and neck that obstructs cerebral venous drainage.
结局指标
主要结局
28-day mortality
时间窗: 28 days
Comparison of patients' deaths 28 days after admission.
次要结局
- Length of hospital stay(From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months)
- Hospital costs(From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months)
- Endotracheal intubation rate(From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months)
- Length of respiratory support(From the date of the non-randomised cohort study until the date of death or discharge from hospital for any reason, whichever comes first, with a maximum assessment period of 3 months)
研究者
Wang xiaorong
Internal medicine physician
Wuhan Union Hospital, China