Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:50 AM
Study NCT ID:
NCT07468266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Airflow in Post-operative Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Power spectral density of EEG', 'timeFrame': 'Before and 10 minutes after initiation of nasal airflow', 'description': 'Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands'}], 'secondaryOutcomes': [{'measure': 'Power spectral density of EEG between interventions', 'timeFrame': '10 minutes after initiation of nasal airflow', 'description': 'Mean PSD will be calculated across beta, alpha, delta and gamma frequency bands and compared between TUI-1 and TUI-2'}, {'measure': 'Coherence', 'timeFrame': 'Before and 10 minutes after initiation of nasal airflow', 'description': 'Inter-regional EEG coherence will be quantified as a measure of functional connectivity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Ventilation']}, 'descriptionModule': {'briefSummary': 'The goal of this investigation is to examine the effect of nasal airflow in invasively ventilated adult patients following planned surgery. The main questions it aims to answer are:\n\n* Does the investigational device produce an effect measured by EEG?\n* Are there differences in effect with modified airflow states?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years of age\n* Receiving sedation via propofol and fentanyl\n* Undergoing surgical procedure with planned post-operative invasive ventilation\n\nExclusion Criteria:\n\n* Pre-existing neurological injury or condition'}, 'identificationModule': {'nctId': 'NCT07468266', 'briefTitle': 'Nasal Airflow in Post-operative Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Impacts of F&P Tui on Cortical Activity in Invasively Ventilated Post-operative Patients', 'orgStudyIdInfo': {'id': 'CIA-358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TUI-A', 'description': 'Receipt of TUI-1 followed by TUI-2', 'interventionNames': ['Device: TUI-1', 'Device: TUI-2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TUI-B', 'description': 'Receipt of TUI-2 followed by TUI-1', 'interventionNames': ['Device: TUI-1', 'Device: TUI-2']}], 'interventions': [{'name': 'TUI-1', 'type': 'DEVICE', 'description': 'Provision of airflow to the nasal cavity by F\\&P Tui at baseline rate', 'armGroupLabels': ['TUI-A', 'TUI-B']}, {'name': 'TUI-2', 'type': 'DEVICE', 'description': 'Provision of airflow to the nasal cavity by F\\&P Tui at modified rate', 'armGroupLabels': ['TUI-A', 'TUI-B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'contacts': [{'name': 'Christopher Hands', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Critical Care Medicine, Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'centralContacts': [{'name': 'Kelly Gradon', 'role': 'CONTACT', 'email': 'kelly.gradon@fphcare.co.nz', 'phone': '09 574 0100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}