Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07048951

Episodes of (Dis)Connected Consciousness in ICU Survivors

This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at least one episode of pharmacological or non-pharmacological coma. The investigators are also investigating the risk factors related to these episodes of consciousness. A follow-up at six months aims to explore the long-term psychological implications of these episodes.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Consciousness Critical Illness Death Disease Attributes ICU Near Death Experience Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU of Liège

Liège, 4000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who survived a ≥7 days stay in the intensive care unit
  • Experienced a pharmacological or non-pharmacological episode of loss of consciousness
  • French speaking

Exclusion criteria

  • Refusal
  • Chronic disorder of consciousness
  • Confusion or delirium
  • Deafness
  • Blindness
  • Aphasia

Treatment and study plan

The Near-Death Experience Content (NDE-C) scale

Diagnostic Test

Questionnaire to detect occurence of NDE. A NDE is identified if score > or = 27/80

Threat perception measure

Other

7 items scale investigating the participant's psychological vulnerability during their stay at the ICU

Interview about the participant's memories of the ICU

Other

Participants will be asked to describe any dream, hallucination, or any other unusual experience they can recall from their stay at the ICU.

Additionally, the participants will be asked to describe any memory they have of the environment of the ICU, such as the appearance of the room, medical staff, family visiting, noises, etc.

Primary outcomes

  1. Detection of potential episodes of disconnected consciousness

    Time frame: Within the week following discharge from the ICU (max 7 days after)

    Near-death experience (using the Near-Death Experience Content scale, min-max: 0-80, with ≥27/80 indicating the presence of a NDE); dream

  2. Detection of potential episodes of connected consciousness

    Time frame: Within the week following discharge from the ICU (max 7 days after)

    Explicit recall of environmental/external stimuli in the ICU

Secondary outcomes

  1. Risk factors

    Time frame: Within the week following discharge from the ICU (max 7 days after)

    (Neuro)physiological marker

  2. Psychological vulnerability during the stay at the ICU

    Time frame: Within the week following discharge from the ICU (max 7 days after)

    Using the Threat Perception Measure, a scale that contains 7 items related to feelings and anxieties perceived by the patient, each scored from 1 to 4, ranging from 1 "Not at all", 2 "A little", 3 "Moderately", and 4 "Extremely", as well as a "don 't remember" category. Min-max: 7-28, with higher scores indicating a higher level of perceived threat

  3. Psychological impact of the stay at the ICU

    Time frame: At a 6 month follow-up after discharge from the ICU

    Any patient who stayed at least 7 days at the ICU is invited to a 6 month follow-up during which they will be presented Hospital Anxiety and Depression Scale (HADS, min-max: 0-42, with higher scores indicating a worse outcome, i.e., more severe symptoms of anxiety or depression), to assess anxiety and depression as well as the Post-Traumatic Stress Assessment Questionnaire (IES-R, min-max: 0-88, with higher scores indicating a worse outcome, i.e., more severe post-traumatic stress symptoms).

    The investigators will be asking two additional questions to investigate a possible impact on the patient's beliefs.

    • Question 1: "Since your stay in intensive care, have your beliefs/opinions changed regarding death?".
    • Question 2: "Has your stay in intensive care modified your fear of health care institutions?

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Martial, PhD

CONTACT

[email protected]

+3243233612

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Centre Hospitalier Universitaire de Liege

Registry information

Official study title

Episodes of (Dis)Connected Consciousness Among Patients Who Survived a Critical Illness

Acronym: CONSCIOUS-ICU

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2025
Registry last updated
Jul 3, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.