- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279171
Near-death Experience in ICU Survivors
March 24, 2022 updated by: Anne-Françoise Rousseau, University of Liege
Incidence of Near-death Experiences Among Patients Who Survived a Critical Illness
This observational study aims to describe the incidence of near-death experience (NDE) in patients who survived a critical illness.
In order to help determine the potential risk factors of NDE, dissociative status and spirituality are also investigated.
Finally, in patients who experienced NDE, a magnetic resonance imaging is performed to search for any structural modifications.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liège, Belgium, 4000
- University Hospital of Liege
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All consecutive patients who survive any critical illness without exclusion criteria may be assessed for NDE occurence
Description
Inclusion Criteria:
- All consecutive patients who survived critical illness
Exclusion Criteria:
- Glasgow Coma Scale < 15/15
- Confusion (CAM ICU scale)
- Refusal
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NDE
Time Frame: Greyson questionnaire is administered during the week following ICU discharge
|
NDE occurence during ICU stay, retrospectively detected by the Greyson scale.
Greyson scale is a 16 items and 32 points scale.
Minimal score is 0, maximal score is 32.
A NDE is suspected when score is equal or higher than 7.
|
Greyson questionnaire is administered during the week following ICU discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life estimation
Time Frame: one year after first interview
|
Quality of life assessment, using EQ-5D-3L
|
one year after first interview
|
NDE
Time Frame: one year after first interview
|
NDE occurence during ICU stay, retrospectively detected by the Greyson scale.
|
one year after first interview
|
MCQ (Memory Characteristics Questionnaire)
Time Frame: one month after first interview
|
analyze of the phenomenological characteristics of real and imagined memories
|
one month after first interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liege
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)
June 1, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
March 24, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMISI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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