Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04471220
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")', 'timeFrame': 'through study completion, an average of 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Difference in 6MWD between four conditions', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'Difference in SpO2 value during 6MWT between four conditions', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'Difference in Pulse rate value during 6MWT between four conditions', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'Difference in Dyspnea during 6MWT between four conditions', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'Difference in lower limb fatigue during 6MWT between four conditions', 'timeFrame': 'through study completion, an average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFNC', '6MWD'], 'conditions': ['High-flow Nasal Cannula', 'Exercise Capacity', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min', 'detailedDescription': 'In the pervious study, the investigators demonstrated that 4 weeks of training using both high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with training using a 6 L/min nasal cannula. However, it was unclear whether the effects of pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic effect. It is also unknown whether there are differences in the effects of pulmonary rehabilitation under HFNC for each underlying disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2 0.21 and a flow rate of 10L/min)\n* Subjects who have been clinically stable for the last 2 weeks\n* Subjects with written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure\n* Subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks\n* Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis obliterans or spinal disease'}, 'identificationModule': {'nctId': 'NCT04471220', 'briefTitle': 'Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC', 'organization': {'class': 'OTHER', 'fullName': 'National Hospital Organization Minami Kyoto Hospital'}, 'officialTitle': 'Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula', 'orgStudyIdInfo': {'id': '2019-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low FIO2 and low flow rate under HFNC', 'description': 'In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 10 L/min).', 'interventionNames': ['Device: High-flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low FIO2 and high flow rate under HFNC', 'description': 'In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min).', 'interventionNames': ['Device: High-flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High FIO2 and low flow rate under HFNC', 'description': 'In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min).', 'interventionNames': ['Device: High-flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High FIO2 and high flow rate under HFNC', 'description': 'In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min).', 'interventionNames': ['Device: High-flow nasal cannula']}], 'interventions': [{'name': 'High-flow nasal cannula', 'type': 'DEVICE', 'description': 'The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.', 'armGroupLabels': ['High FIO2 and high flow rate under HFNC', 'High FIO2 and low flow rate under HFNC', 'Low FIO2 and high flow rate under HFNC', 'Low FIO2 and low flow rate under HFNC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610-0113', 'city': 'Jōyō', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'National Hospital Organization Minami Kyoto Hospital', 'geoPoint': {'lat': 34.84396, 'lon': 135.80561}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hospital Organization Minami Kyoto Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}