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Completed

NCT Number: NCT04619368

Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow up calls

Other

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.

Primary outcomes

  1. 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

  1. psychological disorders measured by QIDS

    Time frame: Month 3

    psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  2. psychological disorders measured by STAI-YA

    Time frame: Month 3

    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  3. psychological disorders measured by QIDS

    Time frame: Month 6

    psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  4. psychological disorders measured by STAI-YA

    Time frame: Month 6

    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  5. psychological disorders measured by QIDS

    Time frame: Month 12

    psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  6. psychological disorders measured by STAI-YA

    Time frame: Month 12

    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  7. quality of life by EQL-5

    Time frame: Month 3

    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life

  8. quality of life by EQL-5

    Time frame: Month 6

    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

  9. quality of life by EQL-5

    Time frame: Month 12

    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

  10. nutritional status

    Time frame: Month 3

    nutritional status measured by Nutritional Risk Screening 2002

  11. nutritional status

    Time frame: Month 6

    nutritional status measured by Nutritional Risk Screening 2002

  12. nutritional status

    Time frame: Month 12

    nutritional status measured by Nutritional Risk Screening 2002

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: RE-CoV-ERY

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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