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

Depression Clinical Trial

— NeuroPsy Réa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838798
• Other study ID #: LOCAL/2012/CR-02
• Secondary ID: 2013-A00022-43
• Status: Completed
• Phase: N/A
• First received: April 21, 2013
• Last updated: October 24, 2016
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Baseline activities
Initial consent procedures and baseline data collection.
• 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
• 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
• 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

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of cognitive impairment	based on D2 test	4 months after ICU discharge	No
Secondary	Duration of sedation		expected average of 48 hours	No
Secondary	Duration of ventilation		expected average of 36 hours	No
Secondary	Daily average for RASS scale		Expected maximum of 28 days	No
Secondary	Daily average for Behaviour pain scale		expected average of 48 hours	No
Secondary	CAM ICU score		upon awakening (expected average of 48 hours)	No
Secondary	Peritraumatic distress inventory		expected average of 5 days (end of ICU stay)	No
Secondary	Questionnaire PDEQ-10		expected average of 5 days (end of ICU stay)	No
Secondary	Assessment of potential impacts		expected average of 5 days (end of ICU stay)	No
Secondary	HADS score		expected average of 5 days (end of ICU stay)	No
Secondary	ICUMT questionnaire		60 +- 3 days after ICU discharge	No
Secondary	ICU-SEQ questionnaire		60 +- 3 days after ICU discharge	No
Secondary	Assessment of psychotramatisme		60 +- 3 days after ICU discharge	No
Secondary	HADS score		60 +- 3 days after ICU discharge	No
Secondary	PCLS scale (DSM IV items)		4 months after ICU discharge	No
Secondary	IDS-C Questionnaire		4 months after ICU discharge	No
Secondary	SF-36		4 months after ICU discharge	No
Secondary	Forward span test		4 months after ICU discharge	No
Secondary	Backwards span test		4 months after ICU discharge	No
Secondary	Rey 15-word test		4 months after ICU discharge	No
Secondary	Test D2 (units = n)		4 months after ICU discharge	No
Secondary	Wisconsin test		4 months after ICU discharge	No
Secondary	Stroop test		4 months after ICU discharge	No
Secondary	Verbal fluency test		4 months after ICU discharge	No