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: Baqiyatallah Medical Sciences University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00515606
• Collaborator: (none)
• Duration (Months): 3.9

Study Details

Study Description

Brief Summary

to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease; Bronchiolitis	Drug: helium:oxygen	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Study Start Date: Feb 1, 2007
• Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. assess spirometry and hemodynamic measures after heliox or air:oxygen use []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 38 Years to 59 Years
• Sexes Eligible for Study: Male

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Baqiyatallah Medical Sciences University

Investigators

• Study Director: Mostafa Ghanei, MD, Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00515606
• Other Study ID Numbers: 210586
• First Posted: Aug 14, 2007
• Last Update Posted: Aug 14, 2007
• Last Verified: Feb 1, 2007

• Additional relevant MeSH terms: Bronchiolitis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 14, 2007