Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 3:25 PM
Study NCT ID:
NCT07048951
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Episodes of (Dis)Connected Consciousness in ICU Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of potential episodes of disconnected consciousness', 'timeFrame': 'Within the week following discharge from the ICU (max 7 days after)', 'description': 'Near-death experience (using the Near-Death Experience Content scale, min-max: 0-80, with ≥27/80 indicating the presence of a NDE); dream'}, {'measure': 'Detection of potential episodes of connected consciousness', 'timeFrame': 'Within the week following discharge from the ICU (max 7 days after)', 'description': 'Explicit recall of environmental/external stimuli in the ICU'}], 'secondaryOutcomes': [{'measure': 'Risk factors', 'timeFrame': 'Within the week following discharge from the ICU (max 7 days after)', 'description': '(Neuro)physiological marker'}, {'measure': 'Psychological vulnerability during the stay at the ICU', 'timeFrame': 'Within the week following discharge from the ICU (max 7 days after)', 'description': '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'}, {'measure': 'Psychological impact of the stay at the ICU', 'timeFrame': 'At a 6 month follow-up after discharge from the ICU', 'description': '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).\n\nThe investigators will be asking two additional questions to investigate a possible impact on the patient\'s beliefs.\n\n* Question 1: "Since your stay in intensive care, have your beliefs/opinions changed regarding death?".\n* Question 2: "Has your stay in intensive care modified your fear of health care institutions?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['near-death experience', 'out-of-body experience'], 'conditions': ['Consciousness', 'Near Death Experience', 'ICU', 'Critical Illness']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients admitted in the ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who survived a ≥7 days stay in the intensive care unit\n* Experienced a pharmacological or non-pharmacological episode of loss of consciousness\n* French speaking\n\nExclusion Criteria:\n\n* Refusal\n* Chronic disorder of consciousness\n* Confusion or delirium\n* Deafness\n* Blindness\n* Aphasia'}, 'identificationModule': {'nctId': 'NCT07048951', 'acronym': 'CONSCIOUS-ICU', 'briefTitle': 'Episodes of (Dis)Connected Consciousness in ICU Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Episodes of (Dis)Connected Consciousness Among Patients Who Survived a Critical Illness', 'orgStudyIdInfo': {'id': '2024-254'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma', 'interventionNames': ['Diagnostic Test: The Near-Death Experience Content (NDE-C) scale', 'Other: Threat perception measure', "Other: Interview about the participant's memories of the ICU"]}], 'interventions': [{'name': 'The Near-Death Experience Content (NDE-C) scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire to detect occurence of NDE. A NDE is identified if score \\> or = 27/80', 'armGroupLabels': ['Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma']}, {'name': 'Threat perception measure', 'type': 'OTHER', 'description': "7 items scale investigating the participant's psychological vulnerability during their stay at the ICU", 'armGroupLabels': ['Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma']}, {'name': "Interview about the participant's memories of the ICU", 'type': 'OTHER', 'description': 'Participants will be asked to describe any dream, hallucination, or any other unusual experience they can recall from their stay at the ICU.\n\nAdditionally, 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.', 'armGroupLabels': ['Survivors of prolonged ICU (≥7days) stay with episode(s) of pharmacological/non-pharmacological coma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Charlotte Martial, PhD', 'role': 'CONTACT', 'email': 'cmartial@uliege.be', 'phone': '+3243233612'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Liege', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}