Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 3:49 AM
Study NCT ID:
NCT00972868
Status:
WITHDRAWN
Last Update Posted:
2017-01-16
First Post:
2009-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Unidirectional Face Mask During NPPV in COPD Patients
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Inability to enrole subjucts.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2009-08-27', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in anatomical dead space and improvement in ventilatory efficiency', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Unidirectional mask', 'NPPV', 'COPD', 'respiratory physiology'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 \\> 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;\n2. Requiring NPPV as assessed by the managing care team.\n\nExclusion Criteria:\n\n1. Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;\n2. Patients who have claustrophobia and cannot wear the mask;\n3. Patients who are hemodynamically unstable;\n4. Patients who are disoriented and unable to cooperate with the study procedure;\n5. DNI or DNR status or patients in whom intubation is contraindicated;\n6. Patients who are currently intubated;\n7. Patients who recently (\\< 6months) had an MI or stroke;\n8. Pregnant woman; There will be no exclusion based on gender, race or ethnicity.'}, 'identificationModule': {'nctId': 'NCT00972868', 'briefTitle': 'A Novel Unidirectional Face Mask During NPPV in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'orgStudyIdInfo': {'id': '2009P000057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD', 'description': 'Thirty adult (\\> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV)', 'interventionNames': ["Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)"]}], 'interventions': [{'name': "A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)", 'type': 'DEVICE', 'description': 'The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period.', 'armGroupLabels': ['COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Yandong Jiang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Robert Kacmarek, PhD, RRT', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia', 'investigatorFullName': 'Yandong Jiang', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}