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Completed

NCT Number: NCT01838798

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline activities

Other

Initial consent procedures and baseline data collection.

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

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

Primary outcomes

  1. Presence/absence of cognitive impairment

    Time frame: 4 months after ICU discharge

    based on D2 test

Secondary outcomes

  1. Duration of sedation

    Time frame: expected average of 48 hours

  2. Duration of ventilation

    Time frame: expected average of 36 hours

  3. Daily average for RASS scale

    Time frame: Expected maximum of 28 days

  4. Daily average for Behaviour pain scale

    Time frame: expected average of 48 hours

  5. CAM ICU score

    Time frame: upon awakening (expected average of 48 hours)

  6. Peritraumatic distress inventory

    Time frame: expected average of 5 days (end of ICU stay)

  7. Questionnaire PDEQ-10

    Time frame: expected average of 5 days (end of ICU stay)

  8. Assessment of potential impacts

    Time frame: expected average of 5 days (end of ICU stay)

  9. HADS score

    Time frame: expected average of 5 days (end of ICU stay)

  10. ICUMT questionnaire

    Time frame: 60 +- 3 days after ICU discharge

  11. ICU-SEQ questionnaire

    Time frame: 60 +- 3 days after ICU discharge

  12. Assessment of psychotramatisme

    Time frame: 60 +- 3 days after ICU discharge

  13. HADS score

    Time frame: 60 +- 3 days after ICU discharge

  14. PCLS scale (DSM IV items)

    Time frame: 4 months after ICU discharge

  15. IDS-C Questionnaire

    Time frame: 4 months after ICU discharge

  16. SF-36

    Time frame: 4 months after ICU discharge

  17. Forward span test

    Time frame: 4 months after ICU discharge

  18. Backwards span test

    Time frame: 4 months after ICU discharge

  19. Rey 15-word test

    Time frame: 4 months after ICU discharge

  20. Test D2 (units = n)

    Time frame: 4 months after ICU discharge

  21. Wisconsin test

    Time frame: 4 months after ICU discharge

  22. Stroop test

    Time frame: 4 months after ICU discharge

  23. Verbal fluency test

    Time frame: 4 months after ICU discharge

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NeuroPsy Réa

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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