Efficacy of the Sit to Stand Test (STST) in the Decision to Hospitalize a Patient Consulting the Emergency Department for COVID 19 (Coronavirus Infectious Disease)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
研究概览
简要总结
As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent specialized care. Therefore, it is essential to develop emergency assessment tools to assess relevant criteria to decide which patients must be kept under hospital monitoring and which patients can be treated on outpatient care.
The aim of this study is to assess the efficacy of STST in the decision to hospitalize patients consulting emergency department for a SARS-Cov2 infection. The investigators wish to show that the addition of this test to the usual hospitalization criteria reduces the proportion of patients hospitalized 48 hours after their first visit to the emergency department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Adult (≥18 years old)
- •Admit to emergency department for suspected SARS-Cov2 infection
- •SARS-CoV2 infection confirmed by Real Time Polymerase Chain Reaction (RT - PCR) before the first discharge of emergency department
- •Patient affiliated or beneficiary of a health care insurance
- •Effective contraception in women of childbearing age. For postmenopausal women, amenorrhea for at least 12 months before the inclusion visit
排除标准
- •Patient presenting criteria for admission to intensive care: signs of acute respiratory distress , respiratory rate> 30 / min, oxygen dependence > 6L / min on face mask for an SpO2 ≥ 95% or an arterial oxygen pressure >8kPa, neurological disorders, systolic blood pressure (SBP) <90mmHg despite fluid resuscitation, lactates> 2mmol / L, bradycardia, or heart rate disorders
- •Patient with SpO2 <90% in spontaneous ventilation in room air at rest
- •Patient with functional impairment or deterioration of the general condition leading to the inability to perform STST
- •Patient with a resting SBP> 180 mmHg or resting diastolic blood pressure (DBP)> 100 mmHg or resting heart rate (HR)> 120 / min
- •Patient with decompensated or unbalanced cardiac pathology
- •Patient previously included in the study following a previous admission to emergency department
- •Patient deprived of liberty, unable to consent freely
- •Patient non affiliated or beneficiary of a health care insurance
研究组 & 干预措施
Conventional arm
For the patients enrolled in this conventional arm, the decision of hospitalisation or discharge will be taken with usual criteria (pulsed oxygen saturation (SpO2) in room air <92% and respiratory rate> 22/min, respiratory rate> 30/min, Blood gas hypoxemia, decompensation of comorbidity, home monitoring not possible, other intercurrent pathology requiring hospitalization, several risk factors for COVID infection requiring hospitalization in intensive care (age> 65y, hypertension complicated by a cardiovascular event, chronic cardiovascular disease, unbalanced diabetes with complications, chronic respiratory disease (excluding well-controlled asthma), chronic renal failure dialysis, obesity, progressive cancer under treatment, congenital or acquired immunosuppression)
Interventional arm
For the patients enrolled in this interventional arm, the decision of hospitalisation or discharge will be taken with usual criteria and the result of Sit to Stand Test.
干预措施: Sit to stand test (Diagnostic Test)
结局指标
主要结局
Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
时间窗: 7 days
次要结局
- Correlation between dyspnea score and the occurrence of an adverse event(7 days)
- Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.(7 days)
- Correlation between heart rate (HR) and the occurrence of an adverse event(7 days)
- Correlation between SpO2 and the occurrence of an adverse event(7 days)
- Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.(7 days)
- Proportion of immediate hospitalizations after the 1st admission at emergency department.(7 days)