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

NCT01838798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Justine Pereira · Centre Hospitalier Universitaire de Nîmes

  • Claire Roger, MD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838798 on ClinicalTrials.gov