Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-04 @ 1:37 PM
Study NCT ID:
NCT04246892
Status:
TERMINATED
Last Update Posted:
2023-08-30
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Alarm Reduction on Delirium in ICU
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'technical problem, no change of the monitors in the ICU ward', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of delirium, according to a ICDSC score>3', 'timeFrame': 'at the end on the ICU stay, an average of 6 days', 'description': 'prevalence of delirium in each group'}], 'secondaryOutcomes': [{'measure': 'prevalence of sub-syndromic delirium in each group, according to a ICDSC score<4 and absence of delirium', 'timeFrame': 'at the end on the ICU stay, an average of 6 days'}, {'measure': 'length of mecanical ventilation (days)', 'timeFrame': 'at the end on the ICU stay, an average of 6 days'}, {'measure': 'length of stay in ICU (days)', 'timeFrame': 'at the end on the ICU stay, an average of 6 days'}, {'measure': 'in patients presenting a delirium, duration of delirium (days) defined by the number of days with a ICDSC score>3', 'timeFrame': 'at the end on the ICU stay, an average of 6 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients admitted to ICU, and who meet inclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years, admission to ICU\n\nExclusion Criteria:\n\n* length of stay in ICU\\<24 hours, moribund patient, deafness, dementia, psychiatric pathology, delirium at admission, acute neurological pathology at admission (stroke, epilepsy, neuro-infection), hepatic encephalopathy, admission for cardiac arrest, admission for voluntary drug intoxication, pregnancy'}, 'identificationModule': {'nctId': 'NCT04246892', 'acronym': 'ALADIN', 'briefTitle': 'Impact of Alarm Reduction on Delirium in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of Alarm Reduction on Delirium in ICU', 'orgStudyIdInfo': {'id': '2019PI225'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group before alarm withdrawal'}, {'label': 'groupe after alarm withdrawal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Lev VOLKOV', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lev VOLKOV', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}