NCT01838798

Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study. The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.

Detailed description

The secondary objectives of this study are: A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit. B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization? C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms? D. To study potential risk factors for cognitive problems at 4 months after ICU discharge. E. If objective C determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization? F. To study potential risk factors for poor quality of life at 4 months:

Conditions

• Stress Disorders, Post-Traumatic
• Depression

Interventions

Type	Name	Description
OTHER	Baseline activities	Initial consent procedures and baseline data collection.
OTHER	Clinical interview with a psychologist	Clinical interview with a psychologist. This interview with a psychologist will take place after patient consent procedures, and at least 2 days after discontinuation of sedation, and before leaving the ICU. This interview will include: * An inventory of peritraumatic distress symptoms * A questionnaire on peritraumatic dissociative experiences * An assessment of related, potential impacts * The HADS questionnaire
OTHER	Telephone interview 2 months after ICU discharge	At 2 months after leaving the ICU, a psychologist will contact the patient with questions regarding his/her representation of hospitalization. This implies the following: * Questionnaires assessing memories and stressors (Questionnaires ICUMT, and ICU-SEQ * An assessment of psychological trauma * An assessment of potential impacts
OTHER	Clinical interview with a psychologist	At 4 months after ICU discharge, the patient has a clinical interview during which a psychologist will: * assess cognitive functions * evaluate clinical symptoms of depression * assess quality of life * assess symptoms of post traumatic stress

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-04-24
• Last updated: 2025-12-19

Locations

1 site across 1 country: France