Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-04 @ 9:05 PM
Study NCT ID:
NCT02083120
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2014-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Physiology of Nasal High Flow Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2014-03-07', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sleep quality', 'timeFrame': 'baseline, after 4 weeks, after 8 weeks, after 12 month', 'description': 'sleep quality, measured by sleep efficiency, e.g. total sleep time vs sleep period time from PSG report.'}], 'primaryOutcomes': [{'measure': 'mean overnight transcutaneous PCO2', 'timeFrame': 'baseline', 'description': 'In two baseline measurements the aim is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.\n\nPrimary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent \\>50 mmHg.'}, {'measure': 'mean overnight transcutaneous PCO2', 'timeFrame': 'after 4 weeks', 'description': 'In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.'}, {'measure': 'mean overnight transcutaneous PCO2', 'timeFrame': 'after 12 month', 'description': 'All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.'}], 'secondaryOutcomes': [{'measure': 'quality of life with Saint Georges Respiratory Questionnaire (SGRQ)', 'timeFrame': 'after 4 weeks, 8 weeks and 12 month', 'description': 'SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high flow', 'COPD', 'AIRVO'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.\n\nThe aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).\n\nHypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.', 'detailedDescription': 'Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.\n\nStage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.\n\nStage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.\n\nStage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.\n\nAll patients will be monitored for the next 12 month. After 6 month there will be a control phone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-80\n* Male and female\n* COPD patients with chronic respiratory insufficiency (pH \\>7.35 and PCO2 \\> 50mmHg)\n* Stable respiratory situation\n\nExclusion Criteria:\n\n* Decompensated heart, liver or kidney failure.\n* Pregnancy or nursing period\n* Participation in another clinical trial within the last 4 weeks\n* Drug abuse\n* Incapable of giving consent\n* Known obstructive sleep apnea syndrome (OSA) (AHI\\>10)\n* noninvasive ventilation (NIV) therapy'}, 'identificationModule': {'nctId': 'NCT02083120', 'briefTitle': 'Efficacy and Physiology of Nasal High Flow Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut für Pneumologie Hagen Ambrock eV'}, 'officialTitle': 'Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure', 'orgStudyIdInfo': {'id': 'AIRVOhome'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nasal High Flow and Oxygen', 'description': 'overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home', 'interventionNames': ['Device: NHF therapy', 'Other: Long term Oxygen Therapy (LOT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long term Oxygen Therapy (LOT)', 'description': 'individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home', 'interventionNames': ['Other: Long term Oxygen Therapy (LOT)']}], 'interventions': [{'name': 'NHF therapy', 'type': 'DEVICE', 'otherNames': ['AIRVO 2', 'myAIRVO 2', 'PT101', 'PT100'], 'description': 'AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.', 'armGroupLabels': ['nasal High Flow and Oxygen']}, {'name': 'Long term Oxygen Therapy (LOT)', 'type': 'OTHER', 'otherNames': ['supplemental oxygen'], 'description': 'Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.', 'armGroupLabels': ['Long term Oxygen Therapy (LOT)', 'nasal High Flow and Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58091', 'city': 'Hagen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Helios Klinik Ambrock', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}], 'overallOfficials': [{'name': 'Georg Nilius, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Klinik Ambrock'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Pneumologie Hagen Ambrock eV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of pneumologic department of Helios Klinik Hagen', 'investigatorFullName': 'Georg Nilius', 'investigatorAffiliation': 'Helios Klinik Ambrock'}}}}