Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03768232
Status:
UNKNOWN
Last Update Posted:
2018-12-07
First Post:
2018-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient', 'timeFrame': 'through study completion an average of 100 days', 'description': 'the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology'}], 'secondaryOutcomes': [{'measure': 'evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient', 'timeFrame': 'through study completion an average of 100 days', 'description': 'evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days'}, {'measure': 'evaluation of two different diaphragmatic thickening fraction formula (DTF)', 'timeFrame': 'through study completion an average of 100 days', 'description': 'evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.'}, {'measure': 'evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient', 'timeFrame': 'through study completion an average of 100 days', 'description': 'evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound assessment', 'diaphragm disfuncion'], 'conditions': ['Respiratory Failure', 'Respiratory Distress Syndrome', 'Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '23641946', 'type': 'RESULT', 'citation': 'Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.'}, {'pmid': '21705883', 'type': 'RESULT', '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': '18367735', 'type': 'RESULT', 'citation': 'Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.'}, {'pmid': '26724302', 'type': 'RESULT', 'citation': 'Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.'}, {'pmid': '29406380', 'type': 'RESULT', 'citation': 'Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.'}, {'pmid': '28930478', 'type': 'RESULT', 'citation': 'Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.'}]}, 'descriptionModule': {'briefSummary': 'evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy', 'detailedDescription': 'Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.\n\nExposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.\n\nVentilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.\n\nExtubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patient admitted in PICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients younger than 18 years old\n* expected clinical requiring of invasive MV for more than 36 hours\n\nExclusion Criteria:\n\n* neonates\n* subjects with preexisting diagnoses of neuromuscular weakness\n* diaphragm paresis\n* chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.'}, 'identificationModule': {'nctId': 'NCT03768232', 'acronym': 'VIDD', 'briefTitle': 'Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrasound asessment', 'type': 'OTHER', 'description': 'US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Matteo Di Nardo', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}