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

NCT ID: NCT04730661

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2021-06-02

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.

Conditions

SARS-CoV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Sit to stand test

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Sit to stand test

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise ARTAUD-MACARI, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology, Thoracic Oncology and Respiratory Intensive Care Unit

Fairuz BOUJIBAR, PhD

Role: STUDY_DIRECTOR

Thoracic Surgery

Locations

Rouen university hospital

Rouen, , France

Countries

France

Other Identifiers

2020/0339/HP

Identifier Type: -

Identifier Source: org_study_id