Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
Study NCT ID:
NCT03844568
Status:
WITHDRAWN
Last Update Posted:
2023-04-12
First Post:
2019-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011015', 'term': 'Pneumonia, Aspiration'}, {'id': 'C564247', 'term': 'Microcephaly, Primary Autosomal Recessive, 6'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Hard to recruit due to COVID-19 issue.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2019-02-15', 'studyFirstSubmitQcDate': '2019-02-15', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical stability-respiration (CS-r)', 'timeFrame': 'up to 2 weeks', 'description': 'time to respiratory stabilization (respiratory rate ≤ 24/min and arterial oxygen saturation ≥ 90% or a partial pressure of oxygen ≥ 60mmHg on room air or usual requirement level)'}], 'secondaryOutcomes': [{'measure': 'Time to clinical stability', 'timeFrame': 'up to 2 weeks', 'description': 'time to clinical stabilization'}, {'measure': 'Early clinical stability rate', 'timeFrame': '3 days', 'description': 'day 3 clinical stability rate'}, {'measure': 'Late clinical stability rate', 'timeFrame': '7 days', 'description': 'day 7 clinical stability rate'}, {'measure': 'Hospital length of stay', 'timeFrame': '1 day (during hospital admission)', 'description': 'length of hospital admission'}, {'measure': 'Radiological improvement', 'timeFrame': '3 and 7 days', 'description': 'improvement of lung infiltration or atelectasis'}, {'measure': 'Broadening of antimicrobial spectrum', 'timeFrame': '1 day (during hospital admission)', 'description': 'escalation antibiotics'}, {'measure': 'Frequency of bronchoscopy for toileting', 'timeFrame': '1 day (during hospital admission)', 'description': 'frequency of invasive lung care like bronchoscopy'}, {'measure': 'In-hospital mortality', 'timeFrame': '1 day (during hospital admission)', 'description': 'all cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aspiration pneumonia', 'continuous positive airway pressure, CPAP'], 'conditions': ['Aspiration Pneumonia']}, 'descriptionModule': {'briefSummary': 'Numerous elderly patients are suffering from aspiration pneumonia due to anatomical or functional predisposing factors including enteral tube feeding, swallowing difficulties, and gastroesophageal reflux disease (GERD). Previous studies have been demonstrated that continuous positive airway pressure (CPAP) is an acceptable means of managing chronic aspiration, atelectasis, and GERD. The purpose of this study is to determine whether nocturnal nasal CPAP is beneficial in patients with aspiration pneumonia and that it would contribute to the rapid clinical stability of aspiration pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* Diagnosis of pneumonia: the presence of new pulmonary infiltration in dependent areas on chest radiographs at the time of hospitalization with at least one of the following\n\n 1. New or increased cough\n 2. Abnormal temperature (\\< 35.6℃ or \\> 37.8℃)\n 3. Abnormal serum leukocyte count (leukocytosis, left shift, or leukopenia)\n* Aspiration tendency or risk factors for frequent or large volume aspiration with at least one of the following\n\n 1. Altered mental status\n 2. Gastrointestinal disorder\n 3. Dysphagia or swallowing difficulties\n 4. Esophageal motility disorders\n 5. Tracheostomy state\n 6. Enteral tube feeding\n* Informed consent\n\nExclusion Criteria:\n\n* Severe hypercapnia (PaCO2 \\> 70mmHg)\n* Respiratory arrest requiring tracheal intubation\n* Cardiac arrest, acute coronary syndrome or life threatening arrhythmias\n* Failure of more than two organs\n* Recent trauma or burns of the neck and face\n* Non- cooperation\n* Pregnancy\n* Withdrawal of consent\n* Refusal of treatment'}, 'identificationModule': {'nctId': 'NCT03844568', 'acronym': 'NAP', 'briefTitle': 'Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Nocturnal Nasal Continuous Positive Airway Pressure in Aspiration Pneumonia', 'orgStudyIdInfo': {'id': 'B-1809-493-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nasal CPAP group', 'description': 'Applying nocturnal nasal continuous positive airway pressure in additional to usual pneumonia treatment', 'interventionNames': ['Device: nocturnal nasal continuous positive airway pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual pneumonia treatment'}], 'interventions': [{'name': 'nocturnal nasal continuous positive airway pressure', 'type': 'DEVICE', 'description': 'applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime', 'armGroupLabels': ['nasal CPAP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Eun Sun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eun Sun Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}