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

Coronavirus Infection Clinical Trial

— RE-CoV-ERY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619368
• Other study ID #: RC31/20/0219
• Status: Recruiting
• Start date: July 27, 2020
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Toulouse
• Contact: Fanny BOUNES, PH
• Phone: 05 61 32 23 11
• Email: Bounes.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Human ARDS
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Follow up calls
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.

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care	Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care	month 12
Secondary	psychological disorders measured by QIDS	psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms	Month 3
Secondary	psychological disorders measured by STAI-YA	psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety	Month 3
Secondary	psychological disorders measured by QIDS	psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms	Month 6
Secondary	psychological disorders measured by STAI-YA	psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety	Month 6
Secondary	psychological disorders measured by QIDS	psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms	Month 12
Secondary	psychological disorders measured by STAI-YA	psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety	Month 12
Secondary	quality of life by EQL-5	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	Month 3
Secondary	quality of life by EQL-5	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	Month 6
Secondary	quality of life by EQL-5	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	Month 12
Secondary	nutritional status	nutritional status measured by Nutritional Risk Screening 2002	Month 3
Secondary	nutritional status	nutritional status measured by Nutritional Risk Screening 2002	Month 6
Secondary	nutritional status	nutritional status measured by Nutritional Risk Screening 2002	Month 12