Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05265351
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2022-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrafast Ultrasound for the Functional Assessment of the Diaphragm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with confirmed or suspected diaphragm dysfunction undergoing transdiaphragmatic pressure measurement in response to phrenic neurostimulation as part of their follow-up or diagnostic. During this examination, ultrafast ultrasound imaging will be performed in diaphragm to capture elicited responses to assess the relationship between the variables derived from the ultrasound of the diaphragm and the variables usually measured during the evaluation of the transdiaphragmatic twitch pressure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant relationship between maximal diaphragm tissue velocity and transdiaphragmatic twitch pressure', 'timeFrame': 'Through study completion, an average of 6 months'}], 'secondaryOutcomes': [{'measure': 'Significant relationship between the diaphragm tissue latency and EMG latency', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'Accurate discrimination between patients with or without diaphragm dysfunction using metrics derived from ultrafast ultrasound', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'Accurate discrimination between patients with or without phrenic conduction abnormality using metrics derived from ultrafast ultrasound', 'timeFrame': 'Through study completion, an average of 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diaphragm', 'Ultrafast ultrasound imaging', 'Electrophysiology', 'Cervical magnetic stimulation', 'Electromyography'], 'conditions': ['Diaphragm Dysfunction']}, 'descriptionModule': {'briefSummary': 'The aims of the current study are as follows:\n\ni) Investigate the relationships between indices derived from ultrafast ultrasound imaging and Pditw, ii) Investigate the relationships between indices derived from ultrafast ultrasound imaging and diaphragm EMG, iii) Investigate the performance of ultrafast ultrasound for the diagnosis of diaphragm dysfunction, iv) Investigate the ability of ultrafast ultrasound imaging to decipher the cause of diaphragm dysfunction i.e. contractility alteration and/or phrenic nerves conduction defect.', 'detailedDescription': 'The Neuromuscular Physiology and Evaluation Laboratory of the Institute of Myology recently reported that artificially stimulated diaphragm contraction may be captured and quantified using ultrafast ultrasound imaging. By filming the diaphragm at very high frame rate, one may extract ultrasound indices such as diaphragm thickening fraction and diaphragm tissue velocity. The same team showed that these indices, in particular, maximal diaphragm tissue velocity were strongly reliable and related to Pditw in healthy subjects. This approach bridges the gap between non-volitional (that are commonly combined with internal pressure measurements) and non-invasive procedures. Whether the relationships between indices derived from ultrafast ultrasound and Pditw exist in patients presenting with actual or suspicion of diaphragm dysfunction remains to be specifically investigated. Similarly, the potential of this approach for the diagnosis of phrenic conduction abnormalities remains to be assessed as it may help to circumvent confounding factors associated with surface EMG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* Patients with confirmed diaphragm dysfunction or suspicion\n* Written informed consent\n* Able to comply with all protocol requirements\n* Affiliate or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Known allergy to latex\n* Known allergy to Lidocaine or similar product\n* Pacemaker\n* Guardianship/trusteeship\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT05265351', 'acronym': 'ECHOSTIM-EFR', 'briefTitle': 'Ultrafast Ultrasound for the Functional Assessment of the Diaphragm', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Myologie, France'}, 'officialTitle': 'Ultrafast Ultrasound for the Functional Assessment of the Diaphragm: Agreement With Standards Mechanical and Electrophysiological Variables and Diagnosis Performance', 'orgStudyIdInfo': {'id': 'ECHOSTIM-EFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with confirmed or suspected diaphragm dysfunction', 'description': 'Diaphragm function will be assess. Surface electromyography of the diaphragm will be performed in parallel. The abdominals displacement will be recorded using strain gauge. The intra-thoracic and intra-abdominal pressure will be measured using esophageal and gastric catheter-balloon.\n\nUltrafast ultrasound imaging will be performed during Cervical and bi-lateral anterior magnetic stimulation, and during phrenic electrical stimulation.', 'interventionNames': ['Diagnostic Test: Transdiaphragmatic pressure measurement', 'Diagnostic Test: EMG']}], 'interventions': [{'name': 'Transdiaphragmatic pressure measurement', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Ultrafast ultrasound imaging'], 'description': 'Ultrafast ultrasound imaging of the diaphragm during artificially evoked responses', 'armGroupLabels': ['Patients with confirmed or suspected diaphragm dysfunction']}, {'name': 'EMG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Surface electromyography of the diaphragm for phrenic nerve conduction study', 'armGroupLabels': ['Patients with confirmed or suspected diaphragm dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian Strauss, MD PhD', 'role': 'CONTACT', 'email': 'christian.straus@aphp.fr', 'phone': '0142178578'}, {'name': 'Thomas Similowski, MD PhD', 'role': 'CONTACT', 'email': 'thomas.similowski@aphp.fr', 'phone': '0142167797'}, {'name': 'Damien Bachasson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian Straus, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas SIMILOWSKI, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin DRES, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudia LLONTOP, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Département R3S - Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Damien BACHASSON, PhD', 'role': 'CONTACT', 'email': 'd.bachasson@institut-myologie.org', 'phone': '01 42 16 66 43'}, {'name': 'Christian STRAUS, Pr', 'role': 'CONTACT', 'email': 'christian.straus@aphp.fr', 'phone': '01 42 17 85 74'}], 'overallOfficials': [{'name': 'Damien BACHASSON, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute ofMyology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Myologie, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}