Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-21 @ 8:59 PM
Study NCT ID:
NCT02696018
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2016-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragmatic Echography in Critically Ill patientS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2016-02-13', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning success', 'timeFrame': 'within the first 48 hours after the spontaneous breathing trial', 'description': 'A successful weaning attempt was registered when patients were extubated and breathed spontaneously for more than 48 hours. The reinstitution of mechanical ventilation at the end of spontaneous breathing trial, reintubation within 48 hours or non-invasive ventilation (NIV) support after extubation defined a failed weaning attempt.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diaphragm', 'Ultrasound', 'Critically ill patients'], 'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '15249460', 'type': 'BACKGROUND', 'citation': 'Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85. doi: 10.1378/chest.126.1.179.'}, {'pmid': '21705883', 'type': 'BACKGROUND', 'citation': 'Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.'}, {'pmid': '24365607', 'type': 'BACKGROUND', 'citation': 'DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.'}, {'pmid': '27677861', 'type': 'DERIVED', 'citation': 'Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.'}]}, 'descriptionModule': {'briefSummary': 'Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been introduced in the clinical practice to evaluate diaphragmatic function. In particular, the investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography. The aim of this study was to compare the diaphragmatic displacement with traditional weaning parameters in potentially ready to be extubated patients undergoing a spontaneous breathing trial (SBT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients undergoing a spontaneous breathing trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mechanically ventilated since more than 24 hours\n* clinical improvement of the underlying acute cause of the respiratory failure\n* adequate cough reflex\n* absence of excessive and/or purulent tracheobronchial secretion\n* stable cardiovascular status\n* stable metabolic status\n* adequate pulmonary function\n* adequate mentation\n\nExclusion Criteria:\n\n* age \\<18 years\n* pregnancy\n* presence of thoracostomy, pneumothorax or pneumomediastinum\n* presence of flail chest or rib fractures\n* neuromuscular disease\n* use of muscle-paralyzing agents within 48 hours before the study\n* history or new detection of paralysis or paradoxical movement of a single hemi-diaphragm on diaphragm ultrasonography'}, 'identificationModule': {'nctId': 'NCT02696018', 'acronym': 'DECIS', 'briefTitle': 'Diaphragmatic Echography in Critically Ill patientS', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Evaluation of Diaphragmatic Displacement During Spontaneous Breathing Trials in Critically Ill Patients', 'orgStudyIdInfo': {'id': '138-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Ultrasonography in critically ill patients in weaning from mechanical ventilation', 'interventionNames': ['Device: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DEVICE', 'description': 'Ultrasonographic assessment of the diaphragm function', 'armGroupLabels': ['Critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44121', 'city': 'Ferrara', 'country': 'Italy', 'facility': "Azienda Ospedaliero Universitaria Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Savino Spadaro', 'investigatorAffiliation': 'Università degli Studi di Ferrara'}}}}