Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT04400461
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2020-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Research Council sum score (MRC- SS).', 'timeFrame': '< 48 hours before ICU discharge', 'description': 'Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.'}, {'measure': 'Medical Research Council sum score (MRC- SS).', 'timeFrame': '< 24 hours before hospital discharge', 'description': 'Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.'}, {'measure': 'The Functional Status Score for the ICU (FSS-ICU)', 'timeFrame': '< 24 hours before hospital discharge', 'description': 'The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks. Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Through study completion, up to 6 months', 'description': 'Age in years'}, {'measure': 'Sex', 'timeFrame': 'Throughout study completion , up to 6 month', 'description': 'Male vs Female'}, {'measure': 'Body Mass Index', 'timeFrame': 'Throughout study completion, up to 6 months', 'description': 'kg/m2'}, {'measure': 'Baseline mobility', 'timeFrame': "First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.", 'description': 'Baseline mobility'}, {'measure': 'APACHE II score', 'timeFrame': '<24 hours after ICU admission', 'description': 'Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.'}, {'measure': 'Length of stay in ICU', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Number of days of stay in ICU'}, {'measure': 'Number of days on mechanical ventilation', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Number of days on mechanical ventilation'}, {'measure': 'Polyneuropathy diagnosis', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Clinical or EMG polyneuropathy diagnosis confirmation'}, {'measure': 'Number of days on Neuromuscular Blockers', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Number of days on NMB during mechanical ventilation'}, {'measure': 'Episodes of prone positioning', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Number of prone positioning episodes during ICU stay'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Total number of days admitted to hospital'}, {'measure': 'Continuation of care', 'timeFrame': 'Throughout the study completion, up to 6 months', 'description': 'Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical function', 'functional outcomes', 'strength', 'intensive care unit', 'rehabilitation'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation. The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation.', 'detailedDescription': "DESIGN: An observation cohort study conducted in a tertiary hospital.\n\nMETHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.\n\nOutcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.\n\nSIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;\n* have received invasive ventilation \\> 24 hours;\n* have been successfully weaned from mechanical ventilation \\> 48 hours;\n* were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise.\n\nExclusion Criteria:\n\n* subjects or proxies with inability to communicate in Spanish fluently;\n* cognitive impairment prior to ICU admission;\n* proven neurological impairment or neuromuscular disorder;\n* Cerebrovascular Accident during hospital stay;\n* previous organ transplant;\n* pregnancy;\n* unstable fractures or any other injuries that would require medical bed rest.'}, 'identificationModule': {'nctId': 'NCT04400461', 'briefTitle': 'Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study', 'orgStudyIdInfo': {'id': '165/20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection and clinical testing of subjects', 'type': 'OTHER', 'description': 'Clinical Testing: muscle strength. Muscle strength, as a component of physical function, will be assessed with the Medical Research Council sum score (MRC- SS) at discharge from the ICU and at discharge from the hospital.\n\nClinical testing: physical function. The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks at discharge from hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Medical ICU. Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Surgical ICU. Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, MSc', 'investigatorFullName': 'Maria Natividad Seisdedos Nunez', 'investigatorAffiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}}}}