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

NCT01838798 | Completed

• 2 other identifiers: LOCAL/2012/CR-022013-A00022-43
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Depression

Keywords

cognitive disorders; quality of life; Intensive care

Outcome Measures

Primary Outcomes (1)

• Presence/absence of cognitive impairment

  based on D2 test

  4 months after ICU discharge

Secondary Outcomes (23)

• Duration of sedation

  expected average of 48 hours

• Duration of ventilation

  expected average of 36 hours

• Daily average for RASS scale

  Expected maximum of 28 days

• Daily average for Behaviour pain scale

  expected average of 48 hours

• CAM ICU score

  upon awakening (expected average of 48 hours)

Study Arms (1)

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

Baseline activities OTHER

Initial consent procedures and baseline data collection.

Study population

Clinical interview with a psychologist 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

Study population

Telephone interview 2 months after ICU discharge 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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Cognitive Dysfunction

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Justine Pereira

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Claire Roger, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2013
• First Posted: April 24, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 19, 2025

Record last verified: 2016-10

Locations

FR (1)