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NCT00515606 Clinical Trial

Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515606
Other study ID # 210586
Secondary ID
Status Completed
Phase Phase 3
First received August 13, 2007
Last updated August 13, 2007
Start date February 2007
Est. completion date June 2007

Study information
Verified date February 2007
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 effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 38 Years to 59 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• helium:oxygen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Baqiyatallah Medical Sciences University

Outcome
Type Measure Description Time frame Safety issue
Primary assess spirometry and hemodynamic measures after heliox or air:oxygen use
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