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

Completed

• Conditions: Stress Disorders, Post-Traumatic; Depression
• Interventions: Other: Baseline activities; Other: Clinical interview with a psychologist; Other: Telephone interview 2 months after ICU discharge

• Registration Number: NCT01838798
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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:

Study Timeline

• Study First Submitted: 2013-04-21
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Study Start: 2013-11
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Telephone interview 2 months after ICU discharge	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 .
Study population	Baseline activities	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 .
Study population	Clinical interview with a psychologist	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 .

Primary Outcome Measures

Name	Time	Method
Presence/absence of cognitive impairment	4 months after ICU discharge	based on D2 test

Secondary Outcome Measures

Name	Time	Method
ICU-SEQ questionnaire	60 +- 3 days after ICU discharge
IDS-C Questionnaire	4 months after ICU discharge
Test D2 (units = n)	4 months after ICU discharge
Wisconsin test	4 months after ICU discharge
Daily average for Behaviour pain scale	expected average of 48 hours
CAM ICU score	upon awakening (expected average of 48 hours)
Peritraumatic distress inventory	expected average of 5 days (end of ICU stay)
Questionnaire PDEQ-10	expected average of 5 days (end of ICU stay)
Assessment of psychotramatisme	60 +- 3 days after ICU discharge
Backwards span test	4 months after ICU discharge
Duration of sedation	expected average of 48 hours
Assessment of potential impacts	expected average of 5 days (end of ICU stay)
HADS score	60 +- 3 days after ICU discharge
Stroop test	4 months after ICU discharge
ICUMT questionnaire	60 +- 3 days after ICU discharge
PCLS scale (DSM IV items)	4 months after ICU discharge
SF-36	4 months after ICU discharge
Forward span test	4 months after ICU discharge
Rey 15-word test	4 months after ICU discharge
Duration of ventilation	expected average of 36 hours
Daily average for RASS scale	Expected maximum of 28 days
Verbal fluency test	4 months after ICU discharge

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France