Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 10:02 AM
Study NCT ID:
NCT01967056
Status:
UNKNOWN
Last Update Posted:
2013-10-22
First Post:
2013-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Respiratory Failure Following Extubation in the SICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-17', 'studyFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2013-10-17', 'lastUpdatePostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Failure', 'timeFrame': '30 days', 'description': 'The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)'}], 'secondaryOutcomes': [{'measure': 'Reintubation within 72 hours', 'timeFrame': '72 hours', 'description': 'The investigators will follow patients and observe whether they require reintubation within 72 h'}, {'measure': 'Non-invasive ventilation for treatment of extubation failure', 'timeFrame': '72 hours', 'description': 'The investigators will follow patients and observe whether they require non-invasive ventilation for extubation failure'}, {'measure': 'Tracheostomy', 'timeFrame': 'Patients will be followed for 30 days of hospitalization'}, {'measure': 'SICU length of stay', 'timeFrame': '180 days'}, {'measure': 'Hospital length of stay', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Muscle strength', 'respiratory failure', 'extubation failure', 'intensive care unit', 'outcome prediction'], 'conditions': ['Muscle Weakness', 'Renal Failure', 'Respiratory Comorbidities']}, 'referencesModule': {'references': [{'pmid': '23571640', 'type': 'BACKGROUND', 'citation': 'Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.'}, {'pmid': '23584384', 'type': 'BACKGROUND', 'citation': 'Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.'}, {'pmid': '21910664', 'type': 'BACKGROUND', 'citation': 'Walcher A, Faubel S, Keniston A, Dennen P. In critically ill patients requiring CRRT, AKI is associated with increased respiratory failure and death versus ESRD. Ren Fail. 2011;33(10):935-42. doi: 10.3109/0886022X.2011.615964. Epub 2011 Sep 13.'}, {'pmid': '23013905', 'type': 'BACKGROUND', 'citation': 'Bittner EA, Schmidt UH. Tracheal reintubation: caused by "too much of a good thing"? Respir Care. 2012 Oct;57(10):1687-91. doi: 10.4187/respcare.02082. No abstract available.'}, {'pmid': '29096229', 'type': 'DERIVED', 'citation': 'Fuchs G, Thevathasan T, Chretien YR, Mario J, Piriyapatsom A, Schmidt U, Eikermann M, Fintelmann FJ. Lumbar skeletal muscle index derived from routine computed tomography exams predict adverse post-extubation outcomes in critically ill patients. J Crit Care. 2018 Apr;44:117-123. doi: 10.1016/j.jcrc.2017.10.033. Epub 2017 Oct 23.'}, {'pmid': '26556899', 'type': 'DERIVED', 'citation': 'Piriyapatsom A, Williams EC, Waak K, Ladha KS, Eikermann M, Schmidt UH. Prospective Observational Study of Predictors of Re-Intubation Following Extubation in the Surgical ICU. Respir Care. 2016 Mar;61(3):306-15. doi: 10.4187/respcare.04269. Epub 2015 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.', 'detailedDescription': "Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.\n\nTe investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.\n\nIn addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.\n\nFinally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of patients used for this study will be those admitted to the Surgical Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years of age or greater)\n* Patients who have been extubated following mechanical ventilation in the surgical ICU\n\nExclusion Criteria:\n\n* Preexisting end-stage renal disease\n* Neurological disorder associated with severe muscle weakness\n* Goals of care focused on comfort'}, 'identificationModule': {'nctId': 'NCT01967056', 'briefTitle': 'Predictors of Respiratory Failure Following Extubation in the SICU', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)', 'orgStudyIdInfo': {'id': '2012P001783'}}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ulrich Schmidt, MD', 'role': 'CONTACT', 'email': 'uschmidt@partners.org', 'phone': '617-643-4408'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Ulrich Schmidt, M.D', 'role': 'CONTACT', 'email': 'uschmidt@partners.org', 'phone': '617-643-4408'}, {'name': 'Jessica Hines', 'role': 'CONTACT', 'email': 'jhines1@partners.org', 'phone': '617-726-2859'}], 'overallOfficials': [{'name': 'Ulrich Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesia', 'investigatorFullName': 'Ulrich Schmidt', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}