Neuropsychological Impact of Hospitalization on Intubated... | NCT01838798

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

NCT01838798

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 19, 2025Actual

Enrollment

125Actual

Phase

Not Applicable

Conditions

Stress Disorders, Post-Traumatic
Depression

Interventions

Baseline activities
Clinical interview with a psychologist
Telephone interview 2 months after ICU discharge
Clinical interview with a psychologist

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2013-A00022-43	Other Identifier	RCB number

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Apr 21, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study population	Experimental	See in inclusion/exclusion criteria. Interventions: Baseline activities; Clinical interview with a psychologist; Telephone interview 2 months after ICU discharge; Clinical interview with a psychologist .	Other: Baseline activities Other: Clinical interview with a psychologist Other: Telephone interview 2 months after ICU discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baseline activities	Other	Initial consent procedures and baseline data collection.	Study population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence/absence of cognitive impairment	based on D2 test	4 months after ICU discharge

Secondary Outcomes

Measure	Description	Time Frame
Duration of sedation		expected average of 48 hours
Duration of ventilation		expected average of 36 hours
Daily average for RASS scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Justine Pereira	Centre Hospitalier Universitaire de Nīmes	Study Director
Claire Roger, MD	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes - Hôpital Universitaire Carémeau		Nîmes		30029	France

ID	Term
D013313	Stress Disorders, Post-Traumatic
D003863	Depression
D060825	Cognitive Dysfunction

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior
D003072	Cognition Disorders
D019965	Neurocognitive Disorders

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health