Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-13 @ 9:45 PM
Study NCT ID:
NCT02292992
Status:
UNKNOWN
Last Update Posted:
2014-12-15
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• End-expiratory lung volume (EELV) determined by electrical impedance tomography after high flow nasal cannula and nasal pillow CPAP', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'Anterior, medio-anterior, medio-posterior and posterior EELV at each time', 'timeFrame': 'at day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electrical impedance tomography', 'Nasal Pillow Continuous Positive Airway Pressure(CPAP)', 'High Flow Nasal Cannula', 'extubation'], 'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The difference of lung volume change will be monitored by electrical impedance tomography before and after use of noninvasive positive pressure ventilation by nasal pillow and high flow nasal cannula in post-extubation patients.', 'detailedDescription': 'Electrical impedance tomography can effectively monitor the lung volume change in ICU patients who were under mechanical ventilator or noninvasive positive pressure ventilator support. Continuous positive airway pressure (CPAP) support by nasal pillow and high flow nasal cannula can improve inspiratory function in extubated patients . However, the extent of lung volume change or functional residual volume (FRC) change by using these two devices were never surveyed before in extubated patients. The investigators will check end-expiratory lung volume (EELV) ,anterior, medio-anterior, medio-posterior and posterior EELV by electrical impedance tomography after use of these two devices in extubated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>20 y/o\n* Any extubated patients after tolerating spontaneous breathing trial\n\nExclusion Criteria:\n\n* Presence of tracheostomy\n* Recent facial trauma\n* Active gastro-intestinal bleeding\n* Do-not-intubate status and\n* Planned use of BiPAP after extubation.\n* Patients with unstable spinal lesions or fractures.\n* BMI\\> 50\n* Patients with a cardiac pacemaker\n* Burn injury with skin defect'}, 'identificationModule': {'nctId': 'NCT02292992', 'briefTitle': 'Lung Volume Change Between Noninvasive Positive Pressure Ventilation by Nasal Pillow and High Flow Nasal Cannula', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'The Difference of Lung Volume Change Detected by Electrical Impedance Tomography (EIT) Between Noninvasive Positive-pressure Ventilation (NIPPV) Support by Nasal Pillow and High Flow Nasal Cannula in Post-extubation Patients', 'orgStudyIdInfo': {'id': '14MMHIS167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal pillow CPAP', 'description': 'Nasal pillow CPAP', 'interventionNames': ['Device: Nasal Pillow CPAP']}], 'interventions': [{'name': 'Nasal Pillow CPAP', 'type': 'DEVICE', 'description': 'Nasal Pillow CPAP in extubated patients', 'armGroupLabels': ['Nasal pillow CPAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuo Li Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kuo Li Kuo, MD', 'role': 'CONTACT', 'email': 'lmn4093@gmail.com', 'phone': '+886975835135'}], 'overallOfficials': [{'name': 'Lee Chao-Hsien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '+886975835770 l49428@mmh.org.tw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}