PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU
研究概览
简要总结
Coronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death.
Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR.
It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors.
It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patient admitted in ICU Lille Hospital and hospitalized in the unit "Emergent Biological Risk" (REB) before a suspicion of infection with COVID-19
- •Clinical infectious syndrome: fever (>38°C) or hypothermia ( 36°C), chill, fever at home
- •a severe respiratory table defined by:
- •Oxygen demand > 3 L/min in the presence of significant comorbidity (pregnancy, chronic respiratory disease, chronic heart disease, hemopathy, cirrhosis) or > 6 L/min in the absence of comorbidity
- •or a respiratory rate > 30 cycles per minute
- •the need for mechanical, invasive or non-invasive ventilation
- •the need for humidified high-flow oxygen therapy
排除标准
- •Patient already included in study for first stay
- •Cirrhosis CHILD C
- •Major surgery in the last 7 days Minor patient
- •Patient under guardianship or curatorship
- •Refusal to participate
- •No social security coverage.
结局指标
主要结局
Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU
时间窗: within 24 hours of admission to ICU
次要结局
- Respiratory dysfunction requiring mechanical ventilation(during ICU stay, up to 28 days)
- Disseminated Intravascular Coagulation (DIC) score(during ICU stay, up to 28 days)
- Hospital anxiety and depression scale (HADS)(at 9 months +/- 3 months after ICU stay)
- Coinfections(during ICU stay, up to 28 days)
- Number of days on vasopressive amines(during ICU stay, up to 28 days)
- Occurrence of an event of venous or arterial thromboembolic disease(during ICU stay, up to 28 days)
- Modified Medical Research Council (MMRC) Dyspnea Scale(at 9 months +/- 3 months after ICU stay)
- Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters(until day 28 after admission of ICU)
- Sequential Organ Failure Assessment (SOFA) Score(during ICU stay, up to 28 days)
- SAPS II score(at admission)
- Number of days with extra renal treatment (ERA)(during ICU stay, up to 28 days)
- Short Form 36(at 9 months +/- 3 months after ICU stay)
- Impact of Event Scale - revised (IES-R)(at 9 months +/- 3 months after ICU stay)
- Viral clearance(through study completion, an average of 28 days)
- Number of patients alive after ICU stay less than 28 days will be tracked(At 28 day)
- Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)(at 9 months +/- 3 months after ICU stay)