Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-02 @ 10:14 AM
Study NCT ID:
NCT07132268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Response in Elderly for Acute Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a severe acute respiratory event within 7 days of admission', 'timeFrame': 'WITHIN 7 DAYS OF ADMISSION', 'description': '* Placement on invasive mechanical ventilation (intubation) or non invasive ventilation (NIV, high-flow oxygen therapy),\n* Respiratory death, confirmed by an independent adjudication committee blinded to the ultrasound results.\n\nExplanatory variable: The presence of impaired diaphragmatic function at admission will be defined by:\n\n* a Tdi (tele-inspiratory thickness) \\<10%, and/or\n* a diaphragmatic excursion \\<10 mm.'}], 'secondaryOutcomes': [{'measure': 'Measurement of diaphragmatic excursion AND Etiology of acute dyspnea', 'timeFrame': 'within 7 days', 'description': 'To study the association between diaphragmatic excursion curve parameters (EDR, inspiratory time, expiratory time, etc.) and the etiology of acute dyspnea in patients aged 75 years and older admitted for acute dyspnea'}, {'measure': 'To evaluate the contribution of diaphragmatic ultrasound to the NEWS2 score performed on admission in predicting the occurrence of acute respiratory distress within 7 days.', 'timeFrame': 'within 7 days', 'description': 'The discriminatory power of the NEWS2 score in predicting the occurrence of acute respiratory distress, the discriminatory power of the NEWS2 score combined with impaired diaphragmatic function on admission ultrasound.\n\nNEWS 2 : The higher the score, the greater the risk of clinical deterioration. 0-4 : low risk Score of 3 in any individual parameter : low-medium 5-6 : moderate risk\n\n\\> or = 7 : high risk'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Dyspnea', 'Acute Respiratory Failure', 'Diaphragmatic Ultrasound']}, 'descriptionModule': {'briefSummary': 'Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 75 years\n* Emergency admission for acute dyspnea\n* Requiring an emergency ultrsoung.\n\nExclusion Criteria:\n\n* Acute respiratory distress requiring immediate invasive or non-invasive ventilation\n* Respiratory rate ≥ 25 breaths/min, and/or SpO2 ≤ 90% on room air, and/or PaO2 ≤ 60 mmHg\n* Known diaphragmatic paralysis\n* Patients with degenerative neuromuscular disease\n* State of shock: systolic blood pressure \\< 90 mmHg and/or mean arterial pressure \\< 65 mmHg and/or presence of skin mottling and/or CTR \\> 3s\n* Lactate levels \\> 2 mmol/L\n* Hypercapnic respiratory acidosis (pH \\< 7.38 and PaCO2 \\> 45 mmHg)\n* Dyspnea due to metabolic acidosis (e.g., diabetic ketoacidosis, renal failure)\n* Dyspnea of traumatic origin\n* Refusal to participate or inability to provide informed consent\n* Patients deprived of liberty\n* Patients under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT07132268', 'acronym': 'DREAM', 'briefTitle': 'Diaphragm Response in Elderly for Acute Monitoring', 'organization': {'class': 'NETWORK', 'fullName': 'Centre Hospitalier de Bethune'}, 'officialTitle': 'Using Diaphragmatic Ultrasound to Predict Acute Respiratory Distress (ARD) in Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea : Prospective Multicenter Study.', 'orgStudyIdInfo': {'id': '2025-01'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2025-A00728-41'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'contacts': [{'name': 'Catherine LE GALL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '62408', 'city': 'Béthune', 'country': 'France', 'contacts': [{'name': 'Mélanie VERLAY', 'role': 'CONTACT', 'email': 'mverlay@ch-lens.fr', 'phone': '0602013068'}, {'role': 'CONTACT', 'email': 'adubart@ch-bethune.fr'}, {'name': 'Tristan CARRIE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alain-Eric DUBART, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Béthune', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'zip': '59507', 'city': 'Douai', 'country': 'France', 'contacts': [{'name': 'Olivier HEMAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Douai', 'geoPoint': {'lat': 50.37069, 'lon': 3.07922}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'contacts': [{'name': 'KWAKYE AGYEMANG Angelo Giordano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Emile Roux', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '77000', 'city': 'Melun', 'country': 'France', 'contacts': [{'name': 'Morsi ELLOUZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Sud Ile-de-France', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'contacts': [{'name': 'Perrine LIBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '50000', 'city': 'Saint-Lô', 'country': 'France', 'contacts': [{'name': 'Félix AMIOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Saint-Lô', 'geoPoint': {'lat': 49.11624, 'lon': -1.09031}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'contacts': [{'name': 'Florent HENIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'contacts': [{'name': 'Alexandre ANDRIES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'centralContacts': [{'name': 'Tristan CARRIE, Doctor', 'role': 'CONTACT', 'email': 'tcarrie@ch-bethune.fr', 'phone': '03.21.64.70.84'}], 'overallOfficials': [{'name': 'Alain-Eric DUBART', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier de Béthune-Beuvry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Bethune', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}