Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation (CognitiVID)
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| ClinicalTrials.gov Identifier: NCT04468035 |
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Recruitment Status :
Recruiting
First Posted : July 13, 2020
Last Update Posted : August 20, 2021
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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.
| Condition or disease |
|---|
| Covid19 |
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS (Acute Respiratory Distress Syndrome) on SARS-CoV2 Viral Pneumonia Requiring Mechanical Ventilation |
| Actual Study Start Date : | June 1, 2020 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
- Medium-term evolution between 3 and 6 months [ Time Frame: 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.
- Cognitive impairment at M3 [ Time Frame: Month 3 ]This outcome corresponds to MMSE orientation score.
- Cognitive impairment at M6 [ Time Frame: Month 6 ]This outcome corresponds to MMSE orientation score.
- Memory Scores at M3 [ Time Frame: Month 3 ]This outcome corresponds to Memory scores.
- Memory Scores at M6 [ Time Frame: Month 6 ]This outcome corresponds to Memory scores.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468035
| Contact: Clément Vialatte de Pémille, MD | 0144127496 ext +33 | cvialatte@ghpsj.fr | |
| Contact: Helene BEAUSSIER, PharmD, pHD | 0144127883 ext +33 | crc@ghpsj.fr |
| France | |
| Groupe Hospitalier Paris Saint-Joseph | Recruiting |
| Paris, France, 75014 | |
| Contact: Clément Vialatte de Pémille, MD 0144127496 ext +33 cvialatte@ghpsj.fr | |
| Principal Investigator: | Clement Vialatte de Pémille, MD | Groupe Hospitalier Paris Saint Joseph |
| Responsible Party: | Groupe Hospitalier Paris Saint Joseph |
| ClinicalTrials.gov Identifier: | NCT04468035 |
| Other Study ID Numbers: |
CognitiVID |
| First Posted: | July 13, 2020 Key Record Dates |
| Last Update Posted: | August 20, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |