An Exploratory Study to Assess Surfactant Levels in COVID-19 Patients Who Will be on Ventilatory Support Due to Severe Respiratory Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Surfactant
研究概览
简要总结
NAME of STUDY: Surfactant levels in the lungs of COVID-19 patients BACKGROUND
- Infection with SARS-CoV-2 may induce respiratory failure.
- COVID-19 associated respiratory failure may require ventilatory support.
- SARS-CoV-2 uses alveolar type II cells for virus replication.
- Alveolar type II cells are responsible for surfactant production and lack of surfactant causes respiratory failure in preterm neonates.
- Lack of surfactant may play role for respiratory failure in COVID-19 patients DESIGN Exploratory prospective study design without therapeutic intervention of any kind. Lung fluid will be donated as part of standard care procedures.
HYPOTHESIS Surfactant is measurable in tracheal secretions by mid-infrared FTIR spectroscopy determined surfactant spectra. Surfactant is reduced in COVID-19 patients requiring ventilator support as compared to non- COVID-19 patients. Dysfunctional surfactant in COVID-19 patients regain its function when respiratory function improves.
POPULATION Main population is patients with COVID-19 pneumonia that requires ventilatory support.
OUTCOME MEASURES Primary outcome is the level of surfactant in lung fluid as obtained by tracheal suction.
SAMPLE SIZE In total 30 patients will be included: twenty COVID-19 patients and 10 non-COVID-19 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients positive for coronavirus 2 (SARS-CoV-2) AND
- •Respiratory failure requiring mechanical ventilation support OR respiratory failure requiring oxygen supplementation AND
- •Age > 18 years AND
- •Permission from next of kin
排除标准
- •Inability to obtain TS or BL as determined by clinical judgement by responsible clinician. Patients with known surfactant dysfunction (such as mutations in the SFTPB or ABCA3 gene). Imminent expected death within 24 hours. Stage 4 severe chronic kidney disease or requiring dialysis. Liver failure. Anticipated transfer to another hospital within 72 hours. Participation in another study which in the opinion of the investigator would prevent enrollment for safety purposes.
结局指标
主要结局
Surfactant
时间窗: Two years
The primary outcome is surfactant levels in lung fluid
次要结局
未报告次要终点
研究者
Henning Bay Nielsen
MD DMSci adj Professor specialist consultant Anesthesia
Zealand University Hospital