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

April 8, 2024 updated by: University of Liege

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Liège, Belgium, 4000
        • Recruiting
        • Chu of Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All adult patients admitted in the resuscitation room

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing Access Criteria

A written agreement between the groups (university or research teams)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Subscribe