Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT05676502
Status:
UNKNOWN
Last Update Posted:
2023-12-01
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas
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': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2', 'timeFrame': '1.5 hours', 'description': 'SurfEMG is measured with EMG system (ADInstruments, NZ), it represents the neural respiratory drive, max ampltude of EMG, unit is mV'}], 'primaryOutcomes': [{'measure': 'Change in minute ventilation (MV) comparing arm 1 and 2', 'timeFrame': '1.5 hours', 'description': 'Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L'}], 'secondaryOutcomes': [{'measure': 'Change in respiratory rate (RR) comparing arm 1 and 2', 'timeFrame': '1.5 hours', 'description': 'Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), RR is calculated. Unit is breath per minute'}, {'measure': 'Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2', 'timeFrame': '1.5 hours', 'description': 'Respiratory effort is measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), (Ti/Te) is calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasal High Flow (NHF)', 'High Flow Nasal Cannula (HFNC)', 'Optiflow', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this controlled randomized crossover study is to compare the physiological effects of nasal high flow therapy (NHF) with 2 different nasal cannulas in patients with exacerbated chronic obstructive pulmonary disease (ECOPD) and chronic respiratory failure.\n\n20 patients will be treated with NHF therapy (Airvo, Fisher\\&Paykel Healthcare, NZ) during wakefulness. Physiological measuremends will take place over three perdiods (visits). One period without NHF, one with NHF via standard cannula (Optiflow M) and one with asymmetrical cannula (Optiflow Duet) in randomised order.', 'detailedDescription': 'Background: Nasal High Flow (NHF) therapy had shown to increase airway pressure, reduce dead space, and improve mucociliary clearance and gas exchange in patients suffering from chronic obstructive pulmonary disease (COPD). The long-term and short-term physiological aspects of NHF are subject of ongoing research. Different flow rates and cannula sizes have been studied and found to yield different therapeutic effects. Larger sized cannulas tend to seal the nares and produce increased positive airway pressure, while smaller cannulas increase the washout effect. Currently, a new cannula is available, with one smaller and one larger opening (Optiflow+ Duet, Fisher\\&Paykel Healthcare, NZ).\n\nProcedure: Following a baseline period without high flow therapy, NHF (35L/min) will be applied via the nasal cannula (Duet or Standard in randomized order). After a wash out phase, the NHF interface will be replaced for another measurement with the respective other cannula (Standard or Duet).\n\nRespiratory rate, tidal volume, minute ventilation, inhalation to exhalation ratio (Ti/Te), transcutaneous pCO2 and intercostal EMG will be recorded during each partial measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation\n* Inpatients with COPD GOLD (2, 3 and 4)\n* Informed Consent\n\nExclusion Criteria:\n\n* Acute respiratory insuffiency with respiratory acidosis (pH\\<7.35)\n* Severe acute physical disease, that do not allow the subject to participate in a clinical trial\n* Language, cognitive, or other barriers that make study participation impossible\n* Pregnancy or Nursing'}, 'identificationModule': {'nctId': 'NCT05676502', 'acronym': 'NHFDuet', 'briefTitle': 'Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas', 'organization': {'class': 'OTHER', 'fullName': 'Kliniken Essen-Mitte'}, 'officialTitle': 'Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)', 'orgStudyIdInfo': {'id': 'NHFDuet 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal High Flow with Optiflow M cannula', 'description': 'Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M)', 'interventionNames': ['Device: AIRVO 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal High Flow with Optiflow Duet Cannula', 'description': 'Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet)', 'interventionNames': ['Device: AIRVO 2']}], 'interventions': [{'name': 'AIRVO 2', 'type': 'DEVICE', 'otherNames': ['Nasal High Flow'], 'description': 'Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.', 'armGroupLabels': ['Nasal High Flow with Optiflow Duet Cannula', 'Nasal High Flow with Optiflow M cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45136', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Nilius', 'role': 'CONTACT', 'email': 'G.Nilius@kem-med.com', 'phone': '+49 201 174', 'phoneExt': '22011'}, {'name': 'Ulrike Domanski', 'role': 'CONTACT', 'email': 'U.Domanski@kem-med.com', 'phone': '+49 201 174', 'phoneExt': '22058'}], 'facility': 'Georg N Nilius', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Georg N Nilius, Prof. Dr. med', 'role': 'CONTACT', 'email': 'G.Nilius@kem-med.com', 'phone': '+49 201 174', 'phoneExt': '22011'}, {'name': 'Ulrike Domanski', 'role': 'CONTACT', 'email': 'U.Domanski@kem-med.com', 'phone': '+49 0201 174', 'phoneExt': '22058'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kliniken Essen-Mitte', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Pneumology, PI', 'investigatorFullName': 'Georg Nilius, Prof. Dr. med', 'investigatorAffiliation': 'Kliniken Essen-Mitte'}}}}