Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT06086769
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Oxygen Therapy Effect on Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056152', 'term': 'Respiratory Rate'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm thickening fraction.', 'timeFrame': 'Immediately after 5 min of each condition (baseline, 20 and 40 liters per minute) the diaphragmatic thickness was measured at the end of inspiration y de la expiration during 3 consecutive respiratory cycles (each cycle is between 3 and 10 seconds)', 'description': 'ultrasound measurements were performed by an expert operator (the same in all cases). The ultrasound measurement was performed using a high-resolution linear transducer in real-time in B-mode.\n\nThe diaphragm thickness was measured at the end of expiration and the end of inspiration of the same ventilatory cycle and the average value of 3 ventilatory cycles was recorded. A 2-minute washout period was allowed between each test condition to avoid the summation of effects.\n\nThe DTf and PTPes/min were calculated for each subject in each available condition (baseline - without flow- , wtih 20 and 40 liters per minute):\n\nDTf = End Inspiratory Diaphragm thickening - End Expiratory Diaphragm thickening / End Expiratory Diaphragm thickening x 100'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': 'The number of breaths per minute was recorded in 60 seconds.', 'description': 'The number of breaths per minute was recorded in 60 seconds.'}, {'measure': 'Esophageal pressure swing (Pes).', 'timeFrame': '5 minutes each condition', 'description': 'Difference between basal Pes and maximum inspiratory Pes deflection.'}, {'measure': 'Esophageal pressure-time product per minute (PTPes/min).', 'timeFrame': 'Through study completion, an average of 24 weeks', 'description': 'It was calculated as the area determined by esophageal deflection multiplied by respiratory rate. An ad hoc software developed in MATLAB R2018b (The MathWorks, Inc. Massachusetts, United States) was used for this purpose.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High flow nasal canula', 'High flow nasal canula therapy', 'Diaphragm thickening fraction', 'Work of breathing', 'Respiratory rate'], 'conditions': ['Healthy Volunteers', 'Diaphragm', 'Respiratory Rate']}, 'descriptionModule': {'briefSummary': 'The use of high-flow nasal cannula (HFNC) has increased. Diaphragmatic ultrasonography is a tool that, as a noninvasive complement to esophageal pressure (Pes) measurement, allows the evaluation of diaphragm function and reflects, through the diaphragm thickening fraction (DTf), the magnitude of diaphragmatic fiber recruitment. The objective of this study was to evaluate the impact of HFNC therapy on the DTf in healthy subjects. Second, this study aimed to assess the behavior of the respiratory rate (RR) and the work of breathing in these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects over 18 years old\n\nExclusion Criteria:\n\n* contraindication for esophageal balloon placement\n* diagnosis of lung disease\n* smokers'}, 'identificationModule': {'nctId': 'NCT06086769', 'briefTitle': 'High Flow Oxygen Therapy Effect on Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Argentinian Intensive Care Society'}, 'officialTitle': 'Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CRIHB #1220 PRISA No. 6256'}}, 'armsInterventionsModule': {'interventions': [{'name': 'High flow nasal canula', 'type': 'DEVICE', 'otherNames': ['diaphragm thickening fraction', 'esophageal pressure swing', 'Respiratory rate'], 'description': 'Measurement of diaphragm thickening fraction, respiratory rate and esophageal pressure swing with calculation of diaphragmatic pressure-time product without the use of HFNC and with the use of HFNC at 20 and 40 Liters per minute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1280AED', 'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Britanico de Buenos Aires'}], 'overallOfficials': [{'name': 'Gustavo A Plotnikow, RT', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Británico de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Argentinian Intensive Care Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gustavo Plotnikow', 'investigatorAffiliation': 'Argentinian Intensive Care Society'}}}}