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Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19 (SITCOV)

Primary Purpose

SARS-CoV Infection

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sit to stand test
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for SARS-CoV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional arm

Interventional arm

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.

Secondary Outcome Measures

Proportion of immediate hospitalizations after the 1st admission at emergency department.
Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.
The adverse events identified are: medical consultation, readmission to the emergency department, hospitalization, hospitalization in intensive care unit, death.
Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.
The adverse events identified are: medical consultation, readmission to the emergency department, hospitalization, hospitalization in intensive care unit, death.
Correlation between SpO2 and the occurrence of an adverse event
the difference between the measurement of SpO2 before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Correlation between heart rate (HR) and the occurrence of an adverse event
the difference between the measurement of HR before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Correlation between dyspnea score and the occurrence of an adverse event
the difference between the measurement of dyspnea score before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.

Full Information

First Posted
January 19, 2021
Last Updated
February 4, 2021
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04730661
Brief Title
Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19
Acronym
SITCOV
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
December 21, 2021 (Anticipated)
Study Completion Date
December 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional arm
Arm Type
No Intervention
Arm Description
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)
Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sit to stand test
Intervention Description
The sit to stand test (or STST) is a test consisting of performing as many sit-to-stand tests as possible in one minute, from a chair without armrests. We note before and during this test, the SpO2 (pulsed oxygen saturation) (rest value and minimum value during exercise), heart rate (HR), dyspnea on the modified Borg scale as well as the number of chair lifts performed. completely and minimum SpO2 during the recovery phase. The possible results from this one-minute test are as follows: If SpO2 <90% or appearance of signs of respiratory distress: Immediate stop of the test and hospitalization SpO2 <90% or decrease in SpO2 ≥ 4% during the test or during the recovery period: Hospitalization SpO2 ≥90% and no decrease in SpO2 ≥ 4% during the test or during the recovery period which will be 3 minutes maximum: discharge.
Primary Outcome Measure Information:
Title
Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Proportion of immediate hospitalizations after the 1st admission at emergency department.
Time Frame
7 days
Title
Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.
Description
The adverse events identified are: medical consultation, readmission to the emergency department, hospitalization, hospitalization in intensive care unit, death.
Time Frame
7 days
Title
Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.
Description
The adverse events identified are: medical consultation, readmission to the emergency department, hospitalization, hospitalization in intensive care unit, death.
Time Frame
7 days
Title
Correlation between SpO2 and the occurrence of an adverse event
Description
the difference between the measurement of SpO2 before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Time Frame
7 days
Title
Correlation between heart rate (HR) and the occurrence of an adverse event
Description
the difference between the measurement of HR before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Time Frame
7 days
Title
Correlation between dyspnea score and the occurrence of an adverse event
Description
the difference between the measurement of dyspnea score before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ELISE ARTAUD-MACARI, MD
Phone
+33232885992
Email
elise.artaud-macari@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise ARTAUD-MACARI, MD
Organizational Affiliation
Pneumology, Thoracic Oncology and Respiratory Intensive Care Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fairuz BOUJIBAR, PhD
Organizational Affiliation
Thoracic Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Rouen university hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ELISE ARTAUD-MACARI, MD
Phone
232885992
Ext
+33
Email
elise.artaud-macari@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
FAIRUZ BOUJIBAR, PhD
Email
fairuz.boujibar@chu-rouen.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19

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