Clinical trial NCT04730661: Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV Infection
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of immediate hospitalizations after the 1st admission at emergency department.
timeFrame: 7 days
measure: Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.
timeFrame: 7 days
measure: Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.
timeFrame: 7 days
measure: Correlation between SpO2 and the occurrence of an adverse event
timeFrame: 7 days
measure: Correlation between heart rate (HR) and the occurrence of an adverse event
timeFrame: 7 days
measure: Correlation between dyspnea score and the occurrence of an adverse event
timeFrame: 7 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen university hospital
Study officials:
affiliation: Pneumology, Thoracic Oncology and Respiratory Intensive Care Unit
name: Elise ARTAUD-MACARI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoracic Surgery
name: Fairuz BOUJIBAR, PhD
role: STUDY_DIRECTOR
References: