- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06362525
Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charlotte Martial, PhD
- Phone Number: +3243233612
- Email: cmartial@uliege.be
Study Contact Backup
- Name: Pauline Fritz, Ms
- Email: pauline.fritz@uliege.be
Study Locations
-
-
-
Liège, Belgium, 4000
- Recruiting
- Chu of Liège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients admitted in the resuscitation room of our university hospital
- French speaking
Exclusion Criteria:
- Refusal
- Chronic disorder of consciousness
- Deafness
- Blindness
- Dementia
- Hemineglect
- Aphasia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
|
|
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
|
upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors
Time Frame: in the resusctiation room admission
|
(neuro)physiological marker; biomarker; cognitive factor
|
in the resusctiation room admission
|
|
Quality of life assessment
Time Frame: at 6-month
|
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.
|
at 6-month
|
|
Memory content and evolution assessment
Time Frame: at 1-month
|
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).
|
at 1-month
|
|
Detection of post-traumatic stress disorder (PTSD)
Time Frame: at 6-month
|
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)
|
at 6-month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States