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

NCT ID: NCT01838798

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Stress Disorders, Post-Traumatic Depression

Keywords

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cognitive disorders quality of life Intensive care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study population

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Interventions: Baseline activities; Clinical interview with a psychologist; Telephone interview 2 months after ICU discharge; Clinical interview with a psychologist .

Group Type EXPERIMENTAL

Baseline activities

Intervention Type OTHER

Initial consent procedures and baseline data collection.

Clinical interview with a psychologist

Intervention Type OTHER

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

Telephone interview 2 months after ICU discharge

Intervention Type OTHER

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

Clinical interview with a psychologist

Intervention Type OTHER

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

Interventions

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Baseline activities

Initial consent procedures and baseline data collection.

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient (or his/her "trusted person") must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
* Patient admitted to the ICU and intubated and ventilated for at least 48 hours

Exclusion Criteria

* The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contra-indication for a treatment used in this study
* Patient admitted to intensive care with sedation started for more than 24 hours
* Patient with neurological or psychiatric (cognitive) disorders
* Patient admitted for cardiac arrest
* Patient admitted for stroke
* Patient admitted for cervical trauma \> C6
* Patient presenting with tracheotomy accompanied by long-term mechanical ventilation
* Moribund patient or with little hope of survival beyond 48 hours
* Patients for whom a limitation or termination of care is considered
* McCabe Score = 0
* Knauss Scale = C or D
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justine Pereira

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Claire Roger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00022-43

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/CR-02

Identifier Type: -

Identifier Source: org_study_id