NCT05197686Unknown不适用
Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia: Prognosis and Impact on the Respiratory and Cardiovascular Systems.
Pomeranian Medical University Szczecin2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lower mortality in HFNC group
研究概览
简要总结
The aim of the study is to compare two methods of oxygen therapy in patients with acute respiratory distress syndrome in the course of SARS-CoV2 pneumonia. The initial method of oxygen supply during coronavirus pneumonia is conventional oxygen therapy using a face mask or nasal cannula. However, there have been reports in the literature that early initiation of high-flow oxygen therapy with a nasal cannula is associated with better prognosis. The study we perform is intended to provide reliable evidence for confirmation this hypothesis.
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 (Investigator)
盲法说明
Groups are designed by web randomizer.
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
- •The diagnosis of a current SARS-CoV2 infection (confirmed RT-PCR test or antigen test [allowed in Poland, with sensitivity ≥90 and specificity ≥97]);
- •Hospitalization in the Oxygen Sector of the Temporary Hospital in Szczecin;
- •Pneumonia during SARS-CoV2 infection;
- •ARDS (PaO 2 / FiO 2 ratio ≤300);
- •Oxygen flow 8-12 l / min on mask with reservoir and ≤ 60 mmHg paO2 and / or SpO2 < 92%;
- •TNo current indications for treatment in the ICU;
- •Permisson of the patient.
排除标准
- •Probable lack of cooperation with patient;
- •Severe Disease disease, eg generalized neoplastic disease;
- •Concomitant pulmonary diseases (eg, fibrosis lungs);
- •Respiratory acidosis - pH <7.3 with pCO2> 50 mmHg;
- •Disturbances of consciousness - GCS < 12;
结局指标
主要结局
Lower mortality in HFNC group
时间窗: 6 months
Lower percent of intubation in HFNC group
时间窗: 6 months
Shorter time of hospitalization in HFNC group
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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