Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-11 @ 11:12 PM
Study NCT ID:
NCT04119505
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': '28 days', 'description': 'Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy) within 28 days from ED admission.'}], 'secondaryOutcomes': [{'measure': 'Delay to initiation of ventilatory support', 'timeFrame': 'at day 28', 'description': 'Ventilatory support is defined as invasive mechanical ventilation or non invasive ventilation or high-flow nasal cannula'}, {'measure': 'Number of patients with adverse events at ED discharge', 'timeFrame': 'through ED stay (up to a day)', 'description': 'Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy).'}, {'measure': 'Number of patients with adverse events at hospital discharge', 'timeFrame': 'through hospital stay (up to a week)', 'description': 'Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragmatic Excursion', 'Diaphragmatic Dysfunction', 'Emergency Department', 'Respiratory insufficiency', 'Acute respiratory failure'], 'conditions': ['Dyspnea', 'Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.\n\nMeasurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .\n\nIn this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED\n\nThe Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission', 'detailedDescription': 'Diaphragmatic dysfunction can be explored by measuring diaphragmatic excursion using ultrasonography in spontaneous ventilation patients.\n\nPatients in spontaneous ventilation will undergo both diaphragmatic excursion measurement at ultrasonography and assessment of the News2 score as part of standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted in the Emergency Department for Acute Respiratory Failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age equal or over 18 y.o\n* Signs of acute respiratory failure defined by RR equal or over 25 br/min and/or signs of increased work of breathing\n* Patients on spontaneous breathing\n\nExclusion criteria:\n\n* Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis\n* Patients on ventilatory support at ED admission or prior to inclusion\n* Patients treated with curare\n* Trauma patients'}, 'identificationModule': {'nctId': 'NCT04119505', 'acronym': 'PREDIRE', 'briefTitle': 'Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.', 'orgStudyIdInfo': {'id': 'RECHMPL19_0141'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Nicolas MARJANOVIC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Poitiers University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Brest', 'class': 'OTHER'}, {'name': 'Nord-Vienne Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}