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

NCT04619368 | Completed

• 1 other identifier: RC31/20/0219
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• psychological disorders measured by QIDS

  Month 3

• psychological disorders measured by STAI-YA

  Month 3

• psychological disorders measured by QIDS

  Month 6

• psychological disorders measured by STAI-YA

  Month 6

• psychological disorders measured by QIDS

  Month 12

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

cohort of all COVID patients who went out alive from intensive care

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections; postintensive care syndrome; Stress Disorders, Post-Traumatic; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections

Study Officials

• Fanny BOUNES

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 6, 2020
• Study Start: July 27, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

FR (1)