Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-04-13 @ 11:41 PM
Study NCT ID:
NCT05950958
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Delirium in ICU Using Multimodal Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with delirium', 'timeFrame': 'From ICU admission up to day 28 or discharge from ICU or death', 'description': 'Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)'}], 'secondaryOutcomes': [{'measure': 'Delirium-free days', 'timeFrame': 'From ICU admission up to day 28 or discharge from ICU or death', 'description': 'Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)'}, {'measure': 'Severity of delirium', 'timeFrame': 'From ICU admission up to day 28 or discharge from ICU or death', 'description': 'Confusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score'}, {'measure': 'Accidental extubation or disconnection of treatment devices', 'timeFrame': 'From ICU admission up to day 28 or discharge from ICU or death', 'description': 'Accidental extubation or disconnection of treatment devices'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': 'From ICU admission up to day 28 or discharge from ICU or death', 'description': 'Duration of ICU and hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'Intensive Care Unit', 'Non-pharmacological intervention'], 'conditions': ['Intensive Care Unit Delirium']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.', 'detailedDescription': 'Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.\n\nSeveral studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.\n\nA randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit\n\nExclusion Criteria:\n\n* Patients who developed delirium before entering the intensive care unit\n* Patients with cognitive impairment\n* Patients who have hearing or vision deficits, or have difficulty in communication\n* Patients who are expected to die within 24 hours or do not want life-sustaining treatment'}, 'identificationModule': {'nctId': 'NCT05950958', 'briefTitle': 'Prevention of Delirium in ICU Using Multimodal Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Delirium_ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal therapy group', 'description': "Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored.\n\nMultimodal therapy with conventional care are provided to prevent delirium. Ongoing orientation: 3 times per day Sensory correction: the hearing device and the glasses are supplied. Cognitive stimulation: a portable monitor is used to provide visual stimulation, and a directional speaker is used to avoid disturbing the alarm of the patient's life supportimng system.\n\nSleep promotion: the lights are turned off from 10 pm to 7 am, and the indirect light source is used if necessary.", 'interventionNames': ['Other: Multimodal therapy for prevention of delirium']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional care group', 'description': 'Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored.\n\nConventional care: If sedation is required, dexmedetomidine is considered as the first-line sedative drug. The sedation is interrupted daily and the possibility of awakening is assessed. Pain with NRS score above 3, is controlled with opioid.\n\nFor patients with Richmond Agitation Sedation Scale (RASS) -4 or -5, possible items are provided.'}], 'interventions': [{'name': 'Multimodal therapy for prevention of delirium', 'type': 'OTHER', 'description': 'Multimodal therapy for prevention of delirium', 'armGroupLabels': ['Multimodal therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Geol Ryu, MD, PhD', 'role': 'CONTACT', 'email': 'hogeol@gmail.com', 'phone': '+82-2072-2065'}, {'name': 'Seung-Young Oh, MD, MS', 'role': 'CONTACT', 'email': 'faun1226@gmail.com', 'phone': '+82-2072-3098'}, {'name': 'Ho Geol Ryu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Leerang Lim, MD', 'role': 'CONTACT', 'email': 'erange@snu.ac.kr', 'phone': '+82-2-2072-2469'}, {'name': 'Ho Geol Ryu, MD, PhD', 'role': 'CONTACT', 'email': 'hogeol@gmail.com', 'phone': '+82-2-2072-2065'}], 'overallOfficials': [{'name': 'Ho Geol Ryu, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ho Geol Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}