Episodes of (Dis)Connected Consciousness in ICU Survivors

NCT07048951 | Recruiting

• 1 other identifier: 2024-254
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Consciousness; Near Death Experience; ICU; Critical Illness

Keywords

near-death experience; out-of-body experience

Outcome Measures

Primary Outcomes (2)

• Detection of potential episodes of disconnected consciousness

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

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

• Detection of potential episodes of connected consciousness

  Explicit recall of environmental/external stimuli in the ICU

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

Secondary Outcomes (3)

• Risk factors

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

• Psychological vulnerability during the stay at the ICU

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

• Psychological impact of the stay at the ICU

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

Study Arms (1)

Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma

Diagnostic Test: The Near-Death Experience Content (NDE-C) scale; Other: Threat perception measure; Other: Interview about the participant's memories of the ICU

Interventions

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

Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma

Threat perception measure OTHER

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

Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma

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.

Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted in the ICU

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead
• Centre Hospitalier Universitaire de Liege: collaborator

Study Sites (1)

CHU of Liège

Liège, Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Death; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Charlotte Martial, PhD

CONTACT

+3243233612; cmartial@uliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: July 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)