Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 3:54 PM
Study NCT ID:
NCT05211661
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples obtained based on venous puncture'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots.', 'timeFrame': '2 years'}, {'measure': 'Cortical control of diaphragm function', 'timeFrame': '2 years', 'description': 'Amplitude of the diaphragm motor evoked potentials (measured by surface electrodes attached to the diaphragm) following cortical magnetic stimulation of the phrenic nerve roots.'}], 'secondaryOutcomes': [{'measure': 'Diaphragm ultrasound', 'timeFrame': '2 years', 'description': 'Diaphragm thickening fraction on ultrasound'}, {'measure': 'Systemic inflammation', 'timeFrame': '2 years', 'description': 'Concentration of circulating Interleukin, high-sensitivity C-reactive protein (analyzed quantitatively based on a Levels venous blood sample).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Issues', 'Mechanical Ventilation Complication', 'Respiratory Failure', 'Intensive Care (ICU) Myopathy']}, 'referencesModule': {'references': [{'pmid': '32396905', 'type': 'BACKGROUND', 'citation': 'Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.'}, {'pmid': '31352459', 'type': 'BACKGROUND', 'citation': 'Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.'}, {'pmid': '31029769', 'type': 'BACKGROUND', 'citation': 'Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.'}, {'pmid': '15020575', 'type': 'BACKGROUND', 'citation': 'Sharshar T, Ross ET, Hopkinson NS, Porcher R, Nickol AH, Jonville S, Dayer MJ, Hart N, Moxham J, Lofaso F, Polkey MI. Depression of diaphragm motor cortex excitability during mechanical ventilation. J Appl Physiol (1985). 2004 Jul;97(1):3-10. doi: 10.1152/japplphysiol.01099.2003. Epub 2004 Mar 12.'}, {'pmid': '29945148', 'type': 'BACKGROUND', 'citation': 'Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation: Revised Edition 2017 - Part 1. Respiration. 2018;96(1):66-97. doi: 10.1159/000488001. Epub 2018 Jun 26.'}, {'pmid': '29945156', 'type': 'BACKGROUND', 'citation': 'Windisch W, Geiseler J, Simon K, Walterspacher S, Dreher M; on behalf of the Guideline Commission. German National Guideline for Treating Chronic Respiratory Failure with Invasive and Non-Invasive Ventilation - Revised Edition 2017: Part 2. Respiration. 2018;96(2):171-203. doi: 10.1159/000488667. Epub 2018 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of Ventilator induced Diaphragm Dysfunction (VIDD) in mechanically ventilated patients over time.\n\nThrough measurements made even after mechanical ventilation (MV) it could be clarified to what extent patients recover from VIDD.\n\nPaired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex.\n\nAgainst that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).', 'detailedDescription': 'Evidence both from animal and human studies support the development of ventilator induced diaphragm dysfunction (VIDD) from as early as 24 hours of mechanical ventilation (MV) in the intensive care unit (ICU).\n\nHowever, while the concept of VIDD seems to be proven now, several questions remain unanswered regarding its actual rate of development and (potentially) recovery after MV.\n\nThe gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of VIDD over time.\n\nThrough measurements made even after MV it could be clarified to what extent patients recover from VIDD.\n\nPaired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex.\n\nAgainst that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Comprehensive assessment of diaphragm atrophy, function, strength and control in patients in whom invasive mechanical ventilation in the Intensive Care Unit had been initiated within 48 hours. Then, serial measurements every third day including 2 measurements after extubation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initiation of invasive mechanical ventilation in the Intensive Care Unit within 48 hours.\n* Expected duration of invasive mechanical ventilation of at least 5 days.\n\nExclusion Criteria:\n\n* Body-mass-index (BMI) \\>40\n* Expected absence of active participation of the patient in study-related measurements after extubation\n* Alcohol or drug abuse\n* Non MRI compatible implant in the body\n* Slipped disc\n* Epilepsy\n* Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.'}, 'identificationModule': {'nctId': 'NCT05211661', 'acronym': 'DAM', 'briefTitle': 'Diaphragm Atrophy and Dysfunction in Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Development of Diaphragm Atrophy, Dysfunction and Inhibited Cortical Control in Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'CTCA 21-279'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Invasively ventilated patients (n=15)', 'description': 'First measurement (comprehensive protocol) within 48 hours from initiation of MV.\n\nSerial measurements every third day including 2 measurements after extubation.', 'interventionNames': ['Diagnostic Test: Respiratory Muscle Testing']}], 'interventions': [{'name': 'Respiratory Muscle Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comprehensive assessment of respiratory muscle function. Comprehensive assessment of respiratory muscle function to the point of its invasive assessment with recordings of twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation and stimulation of the lower thoracic nerve roots.', 'armGroupLabels': ['Invasively ventilated patients (n=15)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Dreher, Professor', 'role': 'CONTACT', 'email': 'mdreher@ukaachen.de', 'phone': '+4924180', 'phoneExt': '88763'}, {'name': 'Jens Spiesshoefer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Binaya Regmi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jonathan Enriquez-Geppert', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mehdi Senol', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RWTH Aachen University', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Michael Dreher, Professor', 'role': 'CONTACT', 'email': 'mdreher@ukaachen.de', 'phone': '+4924180', 'phoneExt': '88763'}, {'name': 'Jens Spiesshoefer, MD', 'role': 'CONTACT', 'email': 'jspiesshoefe@ukaachen.de', 'phone': '+4924180', 'phoneExt': '37036'}], 'overallOfficials': [{'name': 'Michael Dreher, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'RWTH Aachen University Hospital'}, {'name': 'Jens Spiesshoefer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Michael Dreher', 'investigatorFullName': 'Univ.-Prof. Dr. med. Michael Dreher', 'investigatorAffiliation': 'RWTH Aachen University'}}}}