Back to resultsHelium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Primary Purpose
Bronchiolitis, Chronic Bronchitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
helium:oxygen mixture
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchiolitis focused on measuring noninvasive ventilation, helium, oxygen, sulfur mustard, chronic bronchitis, bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- exposure to sulfur mustard
- worsening dyspnea during the last 10 days
- respiratory rate of >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 NIPPV
Sites / Locations
- BMSU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00642447
First Posted
March 19, 2008
Last Updated
March 24, 2008
Sponsor
Baqiyatallah Medical Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT00642447
Brief Title
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Official Title
Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Baqiyatallah Medical Sciences University
4. Oversight
5. Study Description
Brief Summary
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Chronic Bronchitis
Keywords
noninvasive ventilation, helium, oxygen, sulfur mustard, chronic bronchitis, bronchiolitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
helium:oxygen mixture
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
exposure to sulfur mustard
worsening dyspnea during the last 10 days
respiratory rate of >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 NIPPV
Facility Information:
Facility Name
BMSU
City
Tehran
ZIP/Postal Code
19945-546
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
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