Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT04962568
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in DTEE', 'timeFrame': '10 minutes', 'description': 'Evaluation from baseline and between devices'}], 'secondaryOutcomes': [{'measure': 'Changes in DTEI', 'timeFrame': '10 minutes', 'description': 'Evaluation from baseline and between devices'}, {'measure': 'Changes in Dex', 'timeFrame': '10 minutes', 'description': 'Evaluation from baseline and between devices'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Issues', 'Respiratory Failure With Hypoxia', 'Respiratory Failure With Hypercapnia', 'Non-invasive Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute or chronic respiratory failure, hyperemic or hypercapnic\n* age \\> 18 yrs\n* written consent\n\nExclusion Criteria:\n\n* critical disease (intubation, heart failure, lung edema,..)\n* no compliance\n* metabolic acidosis'}, 'identificationModule': {'nctId': 'NCT04962568', 'acronym': 'SENNI', 'briefTitle': 'Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Emden'}, 'officialTitle': 'Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NHF-NIV', 'description': 'Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.', 'interventionNames': ['Diagnostic Test: DTEE', 'Diagnostic Test: DTEI', 'Diagnostic Test: DEx']}, {'type': 'EXPERIMENTAL', 'label': 'NIV-NHF', 'description': 'Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.', 'interventionNames': ['Diagnostic Test: DTEE', 'Diagnostic Test: DTEI', 'Diagnostic Test: DEx']}], 'interventions': [{'name': 'DTEE', 'type': 'DIAGNOSTIC_TEST', 'description': 'endexpiratory diaphragm thickness in mm', 'armGroupLabels': ['NHF-NIV', 'NIV-NHF']}, {'name': 'DTEI', 'type': 'DIAGNOSTIC_TEST', 'description': 'endinspiratory diaphragm thickness in mm', 'armGroupLabels': ['NHF-NIV', 'NIV-NHF']}, {'name': 'DEx', 'type': 'DIAGNOSTIC_TEST', 'description': 'diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm', 'armGroupLabels': ['NHF-NIV', 'NIV-NHF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Bräunlich, MD', 'role': 'CONTACT', 'email': 'highflow@web.de', 'phone': '494921981551'}], 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Bräunlich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor and Investigator', 'investigatorFullName': 'Jens Bräunlich', 'investigatorAffiliation': 'Klinikum Emden'}}}}