NCT06362525

Brief Summary

This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care. Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display. Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Oct 2023Sep 2027

First Submitted

Initial submission to the registry

August 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

April 12, 2024

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

August 29, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

Dream

Outcome Measures

Primary Outcomes (2)

  • Detection of potential episodes of disconnected consciousness

    near-death experience (using the Near-Death Experience Content scale); dream

    upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)

  • Detection of potential episodes of connected consciousness

    explicit recall of environmental/external stimuli upon awakening

    upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)

Secondary Outcomes (4)

  • Risk factors

    in the resusctiation room admission

  • Quality of life assessment

    at 6-month

  • Memory content and evolution assessment

    at 1-month

  • Detection of post-traumatic stress disorder (PTSD)

    at 6-month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients admitted in the resuscitation room

You may qualify if:

  • patients admitted in the resuscitation room of our university hospital
  • French speaking

You may not qualify if:

  • Refusal
  • Chronic disorder of consciousness
  • Deafness
  • Blindness
  • Dementia
  • Hemineglect
  • Aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Critical IllnessDeathUnconsciousnessEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Central Study Contacts

Charlotte Martial, PhD

CONTACT

Pauline Fritz, Ms

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 29, 2023

First Posted

April 12, 2024

Study Start

October 9, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Last Updated

April 12, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Data will be anonymized and shared among collaborators upon reasonable request and agreement

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be shared with collaborators for the specified time allocated to each respective project. Whereas, data shared on the database will be anonymized and available indefinitely.
Access Criteria
A written agreement between the groups (university or research teams)

Locations