Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation

NCT ID: NCT04468035

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-05-23

Brief Summary

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The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2 requires, in its severe forms, the use of invasive ventilation in intensive care.

The first patients seen in intensive care presented with neurological symptoms and usually not seen in non-viral ARDS or due to other viral causes. These were mainly restless awakenings, attempts at self-extubation and confusional syndromes. Although the data in the literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients, certain elements seem to show parenchymal brain damage with the description of hypometabolism of the frontal regions. In addition, most of these patients present a memory complaint after going into intensive care (personal data not published).

We do not know to date what is the cognitive and psychic profile of these patients, nor what will be their future evolution. Some patients may require specific neuro-cognitive rehabilitation.

The aim of this study is to assess the cognitive profile of patients infected with COVID-19 who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital since April 2020, in order to be able to compare them between them and follow their evolution in the medium term. This work could make it possible to describe the specific cognitive impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic disorders, etc.).

The main objective is to follow the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory resuscitation.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Patient whose age ≥ 18 years
* Patient with SARS-CoV2 treated in the intensive care unit of the HPSJ for respiratory distress, using invasive ventilation by oro-tracheal intubation from April 2020
* French speaking patient

Exclusion Criteria

* Patient with an alertness disorder with Glasgow eye score \<3 and / or motor \<6 (confusion being a poor criterion for evaluating the Glasgow score apart from head trauma).
* Patient with impossibility to communicate (mutism, aphonia, major language barrier)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient objecting to the use of his data for this research
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement Vialatte de Pémille, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status

Countries

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France

References

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Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.

Reference Type BACKGROUND
PMID: 32383778 (View on PubMed)

Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15. No abstract available.

Reference Type BACKGROUND
PMID: 32294339 (View on PubMed)

Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.

Reference Type BACKGROUND
PMID: 31762923 (View on PubMed)

Maillet D, Matharan F, Le Clesiau H, Bailon O, Peres K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.

Reference Type BACKGROUND
PMID: 27590305 (View on PubMed)

Vialatte de Pemille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.

Reference Type RESULT
PMID: 35610098 (View on PubMed)

Other Identifiers

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CognitiVID

Identifier Type: -

Identifier Source: org_study_id

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