Health TrialsbyHealthPanel

Episodes of (Dis)Connected Consciousness in ICU Survivors

ConditionsConsciousnessNear Death ExperienceICUCritical Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Liege

About this trial

This single-center observational study aims to describe the incidence of episodes of connected consciousness and disconnected consciousness (including near-death experience (NDE) and out-of-body experiences) in patients who survived a prolonged stay of at least 7 days in the intensive care unit (ICU) and who had at least one episode of pharmacological or non-pharmacological coma. The investigators are also investigating the risk factors related to these episodes of consciousness. A follow-up at six months aims to explore the long-term psychological implications of these episodes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients who survived a ≥7 days stay in the intensive care unit

Experienced a pharmacological or non-pharmacological episode of loss of consciousness

French speaking

Disqualifiers

Refusal

Chronic disorder of consciousness

Confusion or delirium

Deafness

Trial population

All adult patients admitted in the ICU

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • The Near-Death Experience Content (NDE-C) scale

    Diagnostic test

    Questionnaire to detect occurence of NDE. A NDE is identified if score \> or = 27/80

  • Threat perception measure

    Other intervention

    7 items scale investigating the participant's psychological vulnerability during their stay at the ICU

  • Interview about the participant's memories of the ICU

    Other intervention

    Participants will be asked to describe any dream, hallucination, or any other unusual experience they can recall from their stay at the ICU. Additionally, the participants will be asked to describe any memory they have of the environment of the ICU, such as the appearance of the room, medical staff, family visiting, noises, etc.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma3 interventions

Trial outcomes

Primary outcomes

1

Detection of potential episodes of disconnected consciousness

Near-death experience (using the Near-Death Experience Content scale, min-max: 0-80, with ≥27/80 indicating the presence of a NDE); dream

Time frame
Within the week following discharge from the ICU (max 7 days after)
2

Detection of potential episodes of connected consciousness

Explicit recall of environmental/external stimuli in the ICU

Time frame
Within the week following discharge from the ICU (max 7 days after)

Secondary outcomes

1

Risk factors

(Neuro)physiological marker

Time frame
Within the week following discharge from the ICU (max 7 days after)
2

Psychological vulnerability during the stay at the ICU

Using the Threat Perception Measure, a scale that contains 7 items related to feelings and anxieties perceived by the patient, each scored from 1 to 4, ranging from 1 "Not at all", 2 "A little", 3 "Moderately", and 4 "Extremely", as well as a "don 't remember" category. Min-max: 7-28, with higher scores indicating a higher level of perceived threat

Time frame
Within the week following discharge from the ICU (max 7 days after)
3

Psychological impact of the stay at the ICU

Any patient who stayed at least 7 days at the ICU is invited to a 6 month follow-up during which they will be presented Hospital Anxiety and Depression Scale (HADS, min-max: 0-42, with higher scores indicating a worse outcome, i.e., more severe symptoms of anxiety or depression), to assess anxiety and depression as well as the Post-Traumatic Stress Assessment Questionnaire (IES-R, min-max: 0-88, with higher scores indicating a worse outcome, i.e., more severe post-traumatic stress symptoms). The investigators will be asking two additional questions to investigate a possible impact on the patient's beliefs. * Question 1: "Since your stay in intensive care, have your beliefs/opinions changed regarding death?". * Question 2: "Has your stay in intensive care modified your fear of health care institutions?

Time frame
At a 6 month follow-up after discharge from the ICU

Other outcomes

Sponsors and contacts

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University of Liege

Lead sponsor

Centre Hospitalier Universitaire de Liege

Collaborator

Source ClinicalTrials.gov
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