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

Completed

• Conditions: Covid19

• Registration Number: NCT04468035
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medium-term evolution between 3 and 6 months	Month 6	This ouctome corresponds to the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with recourse to ventilatory resuscitation.

Secondary Outcome Measures

Name	Time	Method
Cognitive impairment at M3	Month 3	This outcome corresponds to MMSE orientation score.
Memory Scores at M3	Month 3	This outcome corresponds to Memory scores.
Cognitive impairment at M6	Month 6	This outcome corresponds to MMSE orientation score.
Memory Scores at M6	Month 6	This outcome corresponds to Memory scores.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France