Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 9:37 PM
Study NCT ID:
NCT05591950
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2022-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive validity of the IMS', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Predictive validity of the IMS-score performed in the first 24 hours after admission to the ICU for the length of stay in the ICU'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Mortality during ICU stay'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Duration of invasive mechanical ventilator dependency'}, {'measure': 'Discharge location', 'timeFrame': 'approximate at 28 days (at hospital discharge)', 'description': 'If the patient was discharged home or to another facility at hospital discharge'}, {'measure': 'MRC Score', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Muscle strength at ICU discharge measured using the Medical Research Council score'}, {'measure': 'Muscle strength', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Muscle strength at ICU discharge measured using hand grip strength'}, {'measure': '90-day mortality', 'timeFrame': 'at 90 days', 'description': 'Mortality at 90 days'}, {'measure': '90-day function', 'timeFrame': 'at 90 days', 'description': 'Physical function of the patient at 90 days'}, {'measure': 'IMS during the ICU stay', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)'}, {'measure': 'ICU-LOS', 'timeFrame': 'approximate 28 days (till ICU discharge)', 'description': 'Length of stay in the ICU'}, {'measure': 'Hospital LOS', 'timeFrame': 'approximate 28 days (till discharge)', 'description': 'Length of stay in the hospital'}, {'measure': 'in-hospital mortality', 'timeFrame': 'approximate 28 days (till discharge)', 'description': 'Mortality during the Hospital stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU-mobility-scale'], 'conditions': ['Muscle Weakness', 'Critical Illness', 'Mechanical Ventilation Complication', 'Early Mobilization']}, 'descriptionModule': {'briefSummary': "Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS).\n\nThe subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes intensive care patients who are treated by the Clinic for Anesthesiology with focus on surgical intensive care medicine at the Charité - Universitätsmedizin Berlin for an expected period of more than 24 hours, who are at least 18 years old and receive ventilation support.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill adults (age: ≥ 18 years)\n* Expected length of stay in ICU \\> 24h\n* Ventilation support\n\nExclusion Criteria:\n\n* Patients transferred from other ICUs\n* Patients with pre-existing functional limitations\n* Patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)'}, 'identificationModule': {'nctId': 'NCT05591950', 'acronym': 'TAVIMS', 'briefTitle': 'Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Übersetzung Und Validierung Einer Deutschen Version Der Intensive Care Unit Mobility Scale (IMS) Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)', 'orgStudyIdInfo': {'id': 'TAVIMS'}}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité - Univiversitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Stefan J Schaller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After publication of scientific manuscript.', 'ipdSharing': 'YES', 'description': 'Deidentified data can be requested on reasonable scientific request.', 'accessCriteria': 'Deidentified data can be requested on reasonable scientific request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Clinical Director', 'investigatorFullName': 'Stefan J Schaller', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}