Critical IllnessNCT06362525
Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room
An observational study of Critical Illness and Near-Death Experience, run by University of Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Near-Death Experience, Consciousness, Loss of
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Oct 2023to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients admitted in the resuscitation room
Who may be able to join
- patients admitted in the resuscitation room of our university hospital
- French speaking
Who cannot join
- Refusal
- Chronic disorder of consciousness
- Deafness
- Blindness
- Dementia
- Hemineglect
- Aphasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pauline Fritz, Ms contact
About this study
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.
- Conditions
- Critical Illness, Near-Death Experience, Consciousness, Loss of, Quality of Life, Emergencies
- Keywords
- Dream
- Medical subject headings
- Critical Illness, Death, Unconsciousness, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of potential episodes of disconnected consciousness
near-death experience (using the Near-Death Experience Content scale); dream
Measured: 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
Measured: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
Secondary outcomes (4)
Risk factors
(neuro)physiological marker; biomarker; cognitive factor
Measured: in the resusctiation room admission
Quality of life assessment
The EuroQol five-dimension three-level questionnaire (EQ-5D-3L) comprises two sections. The first one is a five-question descriptive component which explores five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each question has three possible answers, rated from 1 to 3 (no problems, some problems and extreme problems). The second section is a visual analogue scale (EQ VAS; 0 "worst imaginable health state" to 100 "best imaginable health state") about their current health state.
Measured: at 6-month
Memory content and evolution assessment
The Memory Characteristics Questionnaire (MCQ). A total score can be derived summing all the 16 items (each on a 1-7 points Likert scale) and refers to as the amount of memory characteristics (i.e. higher total scores reflect greater amount of memory characteristics).
Measured: at 1-month
Detection of post-traumatic stress disorder (PTSD)
The Posttraumatic Stress Disorder Checklist 5 (PCL-5). Its total score can range from 0 to 80 (scores of ≥31 suggest a probable diagnosis of PTSD)
Measured: at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start9 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362525
- Sponsor's protocol ID
- 2022-389
- Status last verified
- Jun 2023
- First submitted
- 29 Aug 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymized and shared among collaborators upon reasonable request and agreement
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room
- ClinicalTrials.gov ID
- NCT06362525
- Acronym / sponsor ID
- 2022-389
- Conditions
- Critical Illness, Near-Death Experience, Consciousness, Loss of, Quality of Life, Emergencies
- Keywords
- Dream
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted in the resuscitation room
Key inclusion criteria (2 listed)
- patients admitted in the resuscitation room of our university hospital
- French speaking
Key exclusion criteria (7 listed)
- Refusal
- Chronic disorder of consciousness
- Deafness
- Blindness
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of potential episodes of disconnected consciousness
Time frame: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
near-death experience (using the Near-Death Experience Content scale); dream
Detection of potential episodes of connected consciousness
Time frame: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
explicit recall of environmental/external stimuli upon awakening
4 secondary outcomes
Risk factors
Time frame: in the resusctiation room admission
Quality of life assessment
Time frame: at 6-month
Memory content and evolution assessment
Time frame: at 1-month
Detection of post-traumatic stress disorder (PTSD)
Time frame: at 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. Data will be anonymized and shared among collaborators upon reasonable request and agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline Fritz, Ms contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Near-Death Experience, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Martial, PhD (+3243233612, cmartial@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of potential episodes of disconnected consciousness (time frame: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.