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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 November 2016
Main ID:	NCT01838798
Date of registration:	21/04/2013
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients NeuroPsy Réa
Scientific title:	Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients
Date of first enrolment:	November 2013
Target sample size:	125
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01838798
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Justine Pereira
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Name:	Claire Roger, MD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Stress Disorders, Post-Traumatic

Intervention(s)

Other: Telephone interview 2 months after ICU discharge

Other: Baseline activities

Other: Clinical interview with a psychologist

Primary Outcome(s)

Presence/absence of cognitive impairment [Time Frame: 4 months after ICU discharge]

Secondary Outcome(s)

Duration of ventilation [Time Frame: expected average of 36 hours]

Rey 15-word test [Time Frame: 4 months after ICU discharge]

Backwards span test [Time Frame: 4 months after ICU discharge]

HADS score [Time Frame: 60 +- 3 days after ICU discharge]

Assessment of potential impacts [Time Frame: expected average of 5 days (end of ICU stay)]

Daily average for Behaviour pain scale [Time Frame: expected average of 48 hours]

Verbal fluency test [Time Frame: 4 months after ICU discharge]

Forward span test [Time Frame: 4 months after ICU discharge]

Peritraumatic distress inventory [Time Frame: expected average of 5 days (end of ICU stay)]

SF-36 [Time Frame: 4 months after ICU discharge]

CAM ICU score [Time Frame: upon awakening (expected average of 48 hours)]

Daily average for RASS scale [Time Frame: Expected maximum of 28 days]

Wisconsin test [Time Frame: 4 months after ICU discharge]

HADS score [Time Frame: expected average of 5 days (end of ICU stay)]

IDS-C Questionnaire [Time Frame: 4 months after ICU discharge]

Assessment of psychotramatisme [Time Frame: 60 +- 3 days after ICU discharge]

PCLS scale (DSM IV items) [Time Frame: 4 months after ICU discharge]

Stroop test [Time Frame: 4 months after ICU discharge]

Test D2 (units = n) [Time Frame: 4 months after ICU discharge]

Duration of sedation [Time Frame: expected average of 48 hours]

ICU-SEQ questionnaire [Time Frame: 60 +- 3 days after ICU discharge]

ICUMT questionnaire [Time Frame: 60 +- 3 days after ICU discharge]

Questionnaire PDEQ-10 [Time Frame: expected average of 5 days (end of ICU stay)]

Secondary ID(s)

2013-A00022-43

LOCAL/2012/CR-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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