French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

NCT04590170 | Completed

• 1 other identifier: APHP200812
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

Conditions

Covid19

Outcome Measures

Primary Outcomes (44)

• Change on cognitive Impairment: Vigilance (RASS)

  Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on cognitive Impairment: Cooperation

  Yes/no - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on cognitive Impairment: Communication

  Yes/no - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on cognitive Impairment: Agitation

  Yes/no - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on cognitive Impairment: Delirium

  Yes/no - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on cognitive Impairment : Introduction of neuroleptic

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on cognitive Impairment: temporo-spatial disorientation

  Yes/no - Patients group

  Between 10 days and 1 month after ICU's discharge

• Change on physical Impairment : dyspnea

  Yes/No - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment: Modified Borg scale dyspnea score.

  Verbal and numerical scale that asks you to rate the difficulty of your breathing Patients are asked to tick the boxes that reflect their dyspnea perception best range 0-10 lesser is better - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : cough

  Yes/No - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : respiratory rate

  Number of breaths/per minute. - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : ventilation mode

  Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest

  measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : respiratory rate on activity

  respiratory rate breathing rate on activity - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity

  measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow during activity - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : orthostatic hypotension

  Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position. - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : electrocardiogram at rest

  electrocardiogram at rest - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical impairment : numeric verbal scales of fatigue

  self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment: numeric verbal scales of pain

  self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : stiffness or pain involving joints

  Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles) * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : stability of the trunk in siting

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : autonomy for bed-chair transfers

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment autonomy for walking

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment : sores

  Yes/no Localisation * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on Imagery cerebral

  date and result if applicable - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment neurologic exam

  motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score)

  assess muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). MRC-SS score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic). * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on physical Impairment five times sit to stand test

  The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times without use of arms, Equipment • Standard height chair (43-45 cm, 17-18 inches) with a backrest. If the patient cannot perform five stands to complete the test without use of arms, a score of 0 seconds should be documented. * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA)

  Designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstruction skills, conceptual thinking, calculations, and orientation. Range 0 -30 higher is better * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Cognitive Impairment Frontal Assessment Battery (FAB)

  Total score is from a maximum of 18, higher scores indicating better performance. * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : sadness

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : anxiety

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment: Insomnia

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Apathy

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : sideration

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Despair

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Culpability

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Conduit addictive

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : psychiatric or psychologic care

  Yes/no - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• assess type of psychiatric treatment

  Type - Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS)

  A 14-item self-report screening scale that was originally developed to indicate the possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S)

  20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD. * Patients group

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• assess psychological Impairment

  Introduction of antidepressant drugs Type * Patients group

  Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• assess psychological Impairment

  Introduction of neuroleptic Type * Patients group

  change between 10 days and 1 month and 3 months and 6 months after ICU's discharge

Secondary Outcomes (14)

• asses demographics information

  Between 10 days and 1 month after ICU's discharge

• assess comorbidities

  Between 10 days and 1 month after ICU's discharge

• assess past and current medications

  Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

• assess related symptoms nature of COVID-19

  Between 10 days and 1 month after ICU's discharge

• assess characteristics of ongoing hospitalization

  Between 10 days and 1 month after ICU's discharge

Study Arms (2)

Patients with Covid19 infection

Patients with Covid19 infection

Behavioral: Post-intensive Care unit syndrome

Control group

Asymptomatic group

Other: Spatiotemporal measurements of walking

Interventions

Post-intensive Care unit syndrome BEHAVIORAL

Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19

Patients with Covid19 infection

Spatiotemporal measurements of walking OTHER

Spatiotemporal measurements of walking in asymptomatic participants from the general population.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in cochin or Corentin-celton hospitals after an intensive care unit stay for a COVID19 infection

You may qualify if:

• COVID 19 infection (PCR or CT-scan)
• ICU stay requiring mechanical ventilation
• Age ≥18 years old
• Age ≥ 18 years old
• Able to walk without technical assistance,
• Having no orthopedic or neurological disorder likely to disturb balance and walking
• Have not had a severe form of Covid 19 disease in the last 12 months
• Collection of non-opposition

You may not qualify if:

• \- Inability to give consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Department of Rehabilitation, Institute of Rheumatology Cochin

Paris, Paris, 75014, France

Location

Department of Physical Medicine and Rehabilitation

Issy-les-Moulineaux, 92130, France

Location

Related Publications (1)

• Daste C, Ficarra S, Dumitrache A, Cariou A, Lefebvre A, Pene F, Roche N, Roren A, Thery C, Vidal J, Nguyen C, Rannou F, Lefevre-Colau MM. Post-intensive care syndrome in patients surviving COVID-19. Ann Phys Rehabil Med. 2021 Nov;64(6):101549. doi: 10.1016/j.rehab.2021.101549. Epub 2021 Jun 26. No abstract available.

  PMID: 34182168 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Camille DASTE, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: October 30, 2020
• Primary Completion: October 14, 2021
• Study Completion: October 31, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (2)