Critical IllnessNCT04279171
Near-death Experience in ICU Survivors
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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Near-Death Experience
- What is being tested?
- Greyson NDE scale, DES dissociation scale and WHOQOL-SRPB
- How many people
- 126 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who survive any critical illness without exclusion criteria may be assessed for NDE occurence
Who may be able to join
- All consecutive patients who survived critical illness
Who cannot join
- Glasgow Coma Scale < 15/15
- Confusion (CAM ICU scale)
- Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness, Near-Death Experience
- Being tested
- Greyson NDE scale, DES dissociation scale, WHOQOL-SRPB, cerebral magnetic resonance imaging
- Medical subject headings
- Critical Illness, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greyson NDE scaleDiagnostic test
Questionnaire to detect occurence of NDE. A NDE is identified if score > or = 7/32
DES dissociation scaleDiagnostic test
Screening for dissociative symptoms
WHOQOL-SRPBDiagnostic test
WHOQOL-SRPB is an instrument developed to evaluate how spirituality, religiosity and personal beliefs (SRPB) are related to quality of life in health and health care.
cerebral magnetic resonance imagingDiagnostic test
Types of images to be acquired: T1, T2, Diffusion Weighted Imaging-DWI, Fluid Attenuated Inversion Recovery and spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
NDE
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.
Measured: Greyson questionnaire is administered during the week following ICU discharge
Secondary outcomes (3)
Quality of life estimation
Quality of life assessment, using EQ-5D-3L
Measured: one year after first interview
NDE
NDE occurence during ICU stay, retrospectively detected by the Greyson scale.
Measured: one year after first interview
MCQ (Memory Characteristics Questionnaire)
analyze of the phenomenological characteristics of real and imagined memories
Measured: one month after first interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jun 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
- Investigators
- Anne-Françoise Rousseau, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279171
- Sponsor's protocol ID
- EMISI
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rousseau AF, Dams L, Massart Q, Choquer L, Cassol H, Laureys S, Misset B, Dardenne N, Gosseries O, Martial C. Incidence of near-death experiences in patients surviving a prolonged critical illness and their long-term impact: a prospective observational study. Crit Care. 2023 Feb 27;27(1):76. doi: 10.1186/s13054-023-04348-2.
PubMed 36849984
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Near-death Experiences Among Patients Who Survived a Critical Illness
- ClinicalTrials.gov ID
- NCT04279171
- Acronym / sponsor ID
- EMISI
- Conditions
- Critical Illness, Near-Death Experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Feb 2020 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who survive any critical illness without exclusion criteria may be assessed for NDE occurence
Key inclusion criteria (1 listed)
- All consecutive patients who survived critical illness
Key exclusion criteria (3 listed)
- Glasgow Coma Scale < 15/15
- Confusion (CAM ICU scale)
- Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greyson NDE scaleQuestionnaire to detect occurence of NDE. A NDE is identified if score > or = 7/32 | Diagnostic test | – |
| DES dissociation scaleScreening for dissociative symptoms | Diagnostic test | – |
| WHOQOL-SRPBWHOQOL-SRPB is an instrument developed to evaluate how spirituality, religiosity and personal beliefs (SRPB) are related to quality of life in health and health care. | Diagnostic test | – |
| cerebral magnetic resonance imagingTypes of images to be acquired: T1, T2, Diffusion Weighted Imaging-DWI, Fluid Attenuated Inversion Recovery and spectroscopy | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
Quality of life estimation
Time frame: one year after first interview
NDE
Time frame: one year after first interview
MCQ (Memory Characteristics Questionnaire)
Time frame: one month after first interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 36849984Rousseau AF, Dams L, Massart Q, Choquer L, Cassol H, Laureys S, Misset B, Dardenne N, Gosseries O, Martial C. Incidence of near-death experiences in patients surviving a prolonged critical illness and their long-term impact: a prospective observational study. Crit Care. 2023 Feb 27;27(1):76. doi: 10.1186/s13054-023-04348-2.
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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. This study is not recruiting at the moment.
Anne-Françoise Rousseau, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 5 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NDE (time frame: Greyson questionnaire is administered during the week following ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279171, which also lists 1 linked publication.
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 5 Apr 2022.