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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00515606 |
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Date of registration:
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13/08/2007 |
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Primary sponsor: |
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Public title:
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Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard
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Scientific title:
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Date of first enrolment:
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February 2007 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00515606 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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Contacts
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Name:
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Mostafa Ghanei, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- a history of previous exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate >25/min
- arterial pH<7.35
- PaCO2 of >50 mmHg
- PaO2 of <50 mmHg
Exclusion Criteria:
- recent pneumothorax (<1 month)
- severe respiratory failure or hemodynamic instability with forthcoming intubation
- FIO2 of <0.4
- impaired consciousness or absence of patient cooperation
- facial lesions precluding NIV
Age minimum:
38 Years
Age maximum:
59 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Bronchiolitis
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Drug: helium:oxygen
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Primary Outcome(s)
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assess spirometry and hemodynamic measures after heliox or air:oxygen use
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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