Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-12 @ 7:44 AM
Study NCT ID:
NCT05542069
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of the Diaphragm Loading During the Training With a IMT Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-08', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm intervention during a certain percentage of resistive load with a IMT device', 'timeFrame': '1 year', 'description': 'The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.', 'detailedDescription': 'This study has a quasi-experimental design. The investigators will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.\n\nAfter checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy adult volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* healthy subjects\n\nExclusion Criteria:\n\n* without anticoagulation\n* without esophageal lesions\n* without airway lesions\n* without spirometry alterations'}, 'identificationModule': {'nctId': 'NCT05542069', 'briefTitle': 'Measurement of the Diaphragm Loading During the Training With a IMT Device', 'organization': {'class': 'OTHER', 'fullName': 'Clínica Basilea'}, 'officialTitle': 'Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device', 'orgStudyIdInfo': {'id': 'Basilea00000000000000001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Threshold IMT (Inspiratory muscle trainer) by Philips', 'type': 'DEVICE', 'description': 'Apply a resistive load with the IMT device according the maximal inspiratory pressure of each subject.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1078', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Fernando Planells, MD', 'role': 'CONTACT', 'email': 'fmplanells@intramed.net', 'phone': '541144748928'}], 'facility': 'Clinica Basilea', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'centralContacts': [{'name': 'Amelia Matesa, PT', 'role': 'CONTACT', 'email': 'ameliamatesa@gmail.com', 'phone': '541159567515'}], 'overallOfficials': [{'name': 'Dario Villalba, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinica Basilea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clínica Basilea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Dario Villalba', 'investigatorAffiliation': 'Clínica Basilea'}}}}