Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients (NeuroPsy Réa)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients hospitalized in the ICU, intubated and ventilated for at least 48 hours.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study population; 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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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 potential impacts	expected average of 5 days (end of ICU stay)
HADS score	expected average of 5 days (end of ICU stay)
ICUMT questionnaire	60 +- 3 days after ICU discharge
ICU-SEQ questionnaire	60 +- 3 days after ICU discharge
Assessment of psychotramatisme	60 +- 3 days after ICU discharge
HADS score	60 +- 3 days after ICU discharge
PCLS scale (DSM IV items)	4 months after ICU discharge
IDS-C Questionnaire	4 months after ICU discharge
SF-36	4 months after ICU discharge
Forward span test	4 months after ICU discharge
Backwards span test	4 months after ICU discharge
Rey 15-word test	4 months after ICU discharge
Test D2 (units = n)	4 months after ICU discharge
Wisconsin test	4 months after ICU discharge
Stroop test	4 months after ICU discharge
Verbal fluency test	4 months after ICU discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Justine Pereira, Centre Hospitalier Universitaire De Nimes

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 21, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; Intensive care; cognitive disorders
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: LOCAL/2012/CR-02; 2013-A00022-43 (Other Identifier: RCB number)