Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT01743105
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2014-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Sexe', 'timeFrame': 'Baseline (day 0)'}], 'primaryOutcomes': [{'measure': 'Diaphragmatic excursion, first measure by investigator 1', 'timeFrame': 'Baseline (day 0)', 'description': 'in centimeters'}, {'measure': 'Diaphragmatic excursion, first measure by investigator 2', 'timeFrame': 'Baseline (day 0)', 'description': 'in centimeters'}], 'secondaryOutcomes': [{'measure': 'Time necessary to measure diaphragm movement amplitude (minutes)', 'timeFrame': 'Baseline (day 0)'}, {'measure': 'Feasibility (yes/no)', 'timeFrame': 'Baseline (day 0)', 'description': 'We were able to perform the required measurements (yes/no)'}, {'measure': 'Diaphragmatic excursion, second measure by investigator 1', 'timeFrame': 'Baseline (day 0)', 'description': '(centimeters)'}, {'measure': 'Diaphragmatic excursion, second measure by investigator 2', 'timeFrame': 'Baseline (day 0)', 'description': '(centimeters)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diaphragm movement', 'ultrasound', 'emergency room'], 'conditions': ['Respiratory Distress Syndrome, Adult']}, 'referencesModule': {'references': [{'pmid': '27251231', 'type': 'RESULT', 'citation': 'Bobbia X, Clement A, Claret PG, Bastide S, Alonso S, Wagner P, Tison T, Muller L, de La Coussaye JE. Diaphragmatic excursion measurement in emergency patients with acute dyspnea: toward a new diagnostic tool? Am J Emerg Med. 2016 Aug;34(8):1653-7. doi: 10.1016/j.ajem.2016.05.055. Epub 2016 May 24.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.', 'detailedDescription': 'The secondary objectives of this study are:\n\n* To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients).\n* To evaluate the time required for the measurement.\n* To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient has acute respiratory distress defined by a respiratory rate \\> 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) \\<90% and / or pH \\<7.35 and carbon dioxide partial pressure (pCO2) \\> 6 kPa (45 mm Hg)\n* The patient breathes spontaneously (no respirator)\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient or his/her representative refuses to sign the consent\n* It is impossible to correctly inform the patient, or to correctly inform his/her representative\n* The patient is pregnant, parturient, or breastfeeding\n* The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...).\n* Patient admitted with respiratory support treatment in progress\n* Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements"}, 'identificationModule': {'nctId': 'NCT01743105', 'acronym': 'EDDRA-Repro', 'briefTitle': 'Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room', 'orgStudyIdInfo': {'id': 'LOCAL/2012/XBAC-01'}, 'secondaryIdInfos': [{'id': '2012-A01094-39', 'type': 'OTHER', 'domain': 'RCB number'}, {'id': 'Bobbia EDDRA Repro', 'type': 'OTHER', 'domain': 'BESPIM, Nîmes University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study population', 'description': 'The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria.\n\nInterventions: Diaphragm excursion measures 1, Diaphragm excursion measures 2', 'interventionNames': ['Procedure: Diaphragm excursion measures 1', 'Procedure: Diaphragm excursion measures 2']}], 'interventions': [{'name': 'Diaphragm excursion measures 1', 'type': 'PROCEDURE', 'description': 'A first diaphragm ultrasound study will be carried out by investigator 1. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.', 'armGroupLabels': ['Study population']}, {'name': 'Diaphragm excursion measures 2', 'type': 'PROCEDURE', 'description': 'A second diaphragm ultrasound study will be carried out immediately after Ultrasound 1, and by investigator 2. The results are blinded between investigators. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.', 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Xavier Bobbia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}