Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit

NCT ID: NCT04872049

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2021-10-27

Brief Summary

Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.

During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.

The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.

Detailed Description

The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.

In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.

Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.

The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.

Conditions

Intensive Care Unit; SARS-CoV2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Major patients (above 18 years old)
• Admitted in intensive care unit
• Hospitalized more than 2 days (48 hours)
• Between 01/01/2020 and 06/30/2020
• Whether SARS-CoV-2 positive or negative

Exclusion Criteria

• Minor patient
• Protected major (under safeguardship, curatorship or guardianship)
• Patient opposition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire FAZILLEAU

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Arthur Dr JAMES, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

GH Pitié Salpêtrière - Charles Foix

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

2020-A03430-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200450

Identifier Type: -

Identifier Source: org_study_id