NCT04279171

Brief 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. Finally, in patients who experienced NDE, a magnetic resonance imaging is performed to search for any structural modifications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

February 19, 2020

Last Update Submit

March 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Greyson questionnaire is administered during the week following ICU discharge

Secondary Outcomes (3)

  • Quality of life estimation

    one year after first interview

  • NDE

    one year after first interview

  • MCQ (Memory Characteristics Questionnaire)

    one month after first interview

Interventions

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.

Types of images to be acquired: T1, T2, Diffusion Weighted Imaging-DWI, Fluid Attenuated Inversion Recovery and spectroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients who survive any critical illness without exclusion criteria may be assessed for NDE occurence

You may qualify if:

  • All consecutive patients who survived critical illness

You may not qualify if:

  • Glasgow Coma Scale \< 15/15
  • Confusion (CAM ICU scale)
  • Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Critical IllnessDeath

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne-Françoise Rousseau, MD, PhD

    University hospital of Liège

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic, Intensive Care Dpt

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

June 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 5, 2022

Record last verified: 2022-03

Locations