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NCT00642447 Clinical Trial

Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

Bronchiolitis Clinical Trial

Official title:
Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00642447
Other study ID # B12406
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 19, 2008
Last updated March 24, 2008
Start date April 2007

Study information
Verified date March 2008
Source Baqiyatallah Medical Sciences University
Contact n/a
Is FDA regulated No
Health authority Iran: Baqiyatallah Medical Sciences University
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 38 Years to 59 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• helium:oxygen mixture

Locations
Country Name City State
Iran, Islamic Republic of BMSU Tehran

Sponsors (1)
Lead Sponsor Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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