Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 3:59 PM
Study NCT ID:
NCT00515606
Status:
COMPLETED
Last Update Posted:
2007-08-14
First Post:
2007-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001988', 'term': 'Bronchiolitis'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2007-08-13', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-13', 'lastUpdatePostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess spirometry and hemodynamic measures after heliox or air:oxygen use'}]}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease', 'Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '38 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of previous exposure to sulfur mustard\n* worsening dyspnea during the last 10 days\n* respiratory rate \\>25/min\n* arterial pH\\<7.35\n* PaCO2 of \\>50 mmHg\n* PaO2 of \\<50 mmHg\n\nExclusion Criteria:\n\n* recent pneumothorax (\\<1 month)\n* severe respiratory failure or hemodynamic instability with forthcoming intubation\n* FIO2 of \\<0.4\n* impaired consciousness or absence of patient cooperation\n* facial lesions precluding NIV'}, 'identificationModule': {'nctId': 'NCT00515606', 'briefTitle': 'Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard', 'organization': {'class': 'OTHER', 'fullName': 'Baqiyatallah Medical Sciences University'}, 'orgStudyIdInfo': {'id': '210586'}}, 'armsInterventionsModule': {'interventions': [{'name': 'helium:oxygen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mostafa Ghanei, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqiyatallah Medical Sciences University', 'class': 'OTHER'}}}}