Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room

Quality of Life Clinical Trial

Official title:

Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362525
• Other study ID #: 2022-389
• Status: Recruiting
• Start date: October 9, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: Charlotte Martial, PhD
• Phone: +3243233612
• Email: cmartial[@]uliege.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness, Loss of
• Critical Illness
• Death
• Emergencies
• Near-Death Experience
• Quality of Life
• Unconsciousness

Locations

Country	Name	City	State
Belgium	CHU of Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Risk factors	(neuro)physiological marker; biomarker; cognitive factor	in the resusctiation room admission
Secondary	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.	at 6-month
Secondary	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).	at 1-month
Secondary	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)	at 6-month