Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT02552732
Status:
TERMINATED
Last Update Posted:
2020-08-17
First Post:
2015-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nasal High Flow Therapy 30 Day Readmission Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stanislav.tatkov@fphcare.co.nz', 'phone': '09 5740100', 'title': 'Dr Stanislav Tatkov', 'organization': 'Fisher and Paykel Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': 'Over 31 days (1 month)', 'eventGroups': [{'id': 'EG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General unwellness/tired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'AECOPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'NHF Use for 30 Days Following Discharge After AECOPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.\n\nNHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.\n\nNHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6560', 'spread': '2.4137', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after hospital discharge', 'description': 'Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'NHF use for 30 days following discharge after AECOPD. Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'percentage of days of use', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Use Per Day of the myAIRVO 2 During Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0319', 'spread': '3.7065', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First week after hospital discharge', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Use Per Day of the myAIRVO 2 During Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7715', 'spread': '2.236', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Second week after hospital discharge', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Use Per Day of the myAIRVO 2 During Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0447', 'spread': '2.4633', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Third week after hospital discharge', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Use Per Day of the myAIRVO 2 During Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Fourth week after hospital discharge', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Use Per Day on Days of myAIRVO 2 Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4326', 'spread': '3.4917', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'hours per day on days of myAIRVO 2 use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Home Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.\n\nNHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.\n\nNHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study entry', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Where Screened But Were Excluded From Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.\n\nNHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.\n\nNHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study completion', 'description': 'Number of participants who withdrew from study after enrollment, up to 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reasons for Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'title': 'AECOPD', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Other Respiratory', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Non-respiratory', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'description': 'AECOPD, other respiratory cause or other cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Those That Had at Least One Hospital Readmission: Number of Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'readmission/participant', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Those That Had at Least One Hospital Readmission: Hospital Readmission Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One ED Visit Within 30 Days of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reason for ED Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'description': 'ED visit due to AECOPD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One GP Visit Within 30 Days of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LACE Index for Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.069', 'spread': '1.4188', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days after hospital discharge', 'description': 'The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FEV1 at Day 1 and 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0042', 'spread': '0.1973', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1st and 31st day after hospital discharge', 'description': 'FEV1 change from day 1 to day 31', 'unitOfMeasure': 'litres per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SVC(in) at Day 1 and 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0027', 'spread': '0.393', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1st and 31st day after hospital discharge', 'description': 'Slow Vital Capacity (inspiratory) change from day 1 to day 31', 'unitOfMeasure': 'litres per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FVC Change From Day 1 to Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.075', 'spread': '0.3306', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1st and 31st day after hospital discharge', 'unitOfMeasure': 'litres per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NHF With or Without Oxygen', 'description': 'Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2.\n\nNHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.\n\nNHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Used Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Completed Week 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Completed Week 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Completed Week 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Completed Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Completed Day 1 and Day 31 Spirometry', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Day 1 SpO2 > 96%', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NHF With or Without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge\n\nNHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.34', 'spread': '10.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'NZ European', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Maori', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-20', 'size': 955376, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-19T03:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Study terminated due to change in business of US site.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2015-09-15', 'resultsFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-08', 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NHF Use for 30 Days Following Discharge After AECOPD', 'timeFrame': '30 days after hospital discharge', 'description': 'Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Average Use Per Day of the myAIRVO 2 During Week 1', 'timeFrame': 'First week after hospital discharge'}, {'measure': 'Average Use Per Day of the myAIRVO 2 During Week 2', 'timeFrame': 'Second week after hospital discharge'}, {'measure': 'Average Use Per Day of the myAIRVO 2 During Week 3', 'timeFrame': 'Third week after hospital discharge'}, {'measure': 'Average Use Per Day of the myAIRVO 2 During Week 4', 'timeFrame': 'Fourth week after hospital discharge'}, {'measure': 'Average Use Per Day on Days of myAIRVO 2 Use', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Number of Participants Using Home Oxygen', 'timeFrame': 'At study entry'}, {'measure': 'Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Number of Participants Who Where Screened But Were Excluded From Enrollment', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days', 'timeFrame': 'At study completion', 'description': 'Number of participants who withdrew from study after enrollment, up to 30 days'}, {'measure': 'Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Reasons for Hospital Admissions', 'timeFrame': '30 days after hospital discharge', 'description': 'AECOPD, other respiratory cause or other cause'}, {'measure': 'In Those That Had at Least One Hospital Readmission: Number of Readmissions', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'In Those That Had at Least One Hospital Readmission: Hospital Readmission Length', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Number of Participants With at Least One ED Visit Within 30 Days of Discharge', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'Reason for ED Visits', 'timeFrame': '30 days after hospital discharge', 'description': 'ED visit due to AECOPD'}, {'measure': 'Number of Participants With at Least One GP Visit Within 30 Days of Discharge', 'timeFrame': '30 days after hospital discharge'}, {'measure': 'LACE Index for Hospital Admissions', 'timeFrame': '30 days after hospital discharge', 'description': 'The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission.'}, {'measure': 'FEV1 at Day 1 and 31', 'timeFrame': '1st and 31st day after hospital discharge', 'description': 'FEV1 change from day 1 to day 31'}, {'measure': 'SVC(in) at Day 1 and 31', 'timeFrame': '1st and 31st day after hospital discharge', 'description': 'Slow Vital Capacity (inspiratory) change from day 1 to day 31'}, {'measure': 'FVC Change From Day 1 to Day 31', 'timeFrame': '1st and 31st day after hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease', 'COPD']}, 'descriptionModule': {'briefSummary': 'The aim of this feasibility study is to provide data for a subsequent randomized controlled trial to investigate if patient outcomes will be improved after an acute COPD exacerbation using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility study will investigate the following: process, resources, management and scientific aspects of delivering NHF as an adjunct therapy in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Male and female\n* Admitted to the respiratory ward(s) of either recruiting hospitals with AECOPD as the primary diagnostic reason for admission.\n\nExclusion Criteria:\n\n* Given a new home oxygen therapy prescription during the current hospital admission\n* The investigator believes the participant or their care giver will be unable to safely use the myAIRVO 2 device following discharge\n* They have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results"}, 'identificationModule': {'nctId': 'NCT02552732', 'acronym': 'N3ADS', 'briefTitle': 'Nasal High Flow Therapy 30 Day Readmission Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study', 'orgStudyIdInfo': {'id': 'CIA138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NHF with or without Oxygen', 'description': 'NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge', 'interventionNames': ['Device: NHF with or without Oxygen']}], 'interventions': [{'name': 'NHF with or without Oxygen', 'type': 'DEVICE', 'description': 'NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.', 'armGroupLabels': ['NHF with or without Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': 'Alana HealthCare', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '6242', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Medical Research Institute of New Zealand', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'James Fingleton, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Research Institute of New Zealand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical Research Institute of New Zealand', 'class': 'OTHER'}, {'name': 'Alana Healthcare', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}