Clinical trial NCT04619368: Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19
Official title: Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human ARDS
Coronavirus Infection
Keywords: Post-intensive care Syndrome
Acute Respiratory Distress Syndrome
quality of life
intensive care unit
PTSD
follow-up after ICU
COVID-19
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cohort of all COVID patients who went out alive from intensive care

Brief summary: For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.

The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).

Detailed description: Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.

Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.

The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.

Eligibility criteria: Inclusion Criteria:

* adult patient
* hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)
* intubated and ventilated
* supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio \<300 mmHg)
* with an rt-PCR positive to SARS-CoV-2
* affiliated to the french social security

Exclusion Criteria:

* minor patient
* patient under protective measure
* ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2

Primary outcomes:
measure: Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
timeFrame: month 12
Secondary outcomes:
measure: psychological disorders measured by QIDS
timeFrame: Month 3
measure: psychological disorders measured by STAI-YA
timeFrame: Month 3
measure: psychological disorders measured by QIDS
timeFrame: Month 6
measure: psychological disorders measured by STAI-YA
timeFrame: Month 6
measure: psychological disorders measured by QIDS
timeFrame: Month 12
measure: psychological disorders measured by STAI-YA
timeFrame: Month 12
measure: quality of life by EQL-5
timeFrame: Month 3
measure: quality of life by EQL-5
timeFrame: Month 6
measure: quality of life by EQL-5
timeFrame: Month 12
measure: nutritional status
timeFrame: Month 3
measure: nutritional status
timeFrame: Month 6
measure: nutritional status
timeFrame: Month 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny BOUNES
role: PRINCIPAL_INVESTIGATOR
References: