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Clinical Trials/NCT04619368
NCT04619368
Unknown
Not Applicable

Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)

University Hospital, Toulouse1 site in 1 country100 target enrollmentJuly 27, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human ARDS
Sponsor
University Hospital, Toulouse
Enrollment
100
Locations
1
Primary Endpoint
Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2020
End Date
July 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care

Time Frame: month 12

Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care

Secondary Outcomes

  • psychological disorders measured by STAI-YA(Month 12)
  • nutritional status(Month 12)
  • psychological disorders measured by QIDS(Month 12)
  • quality of life by EQL-5(Month 12)

Study Sites (1)

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