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

This study has been completed.

First Received: August 13, 2007 No Changes Posted

Sponsored by:	Baqiyatallah Medical Sciences University
Information provided by:	Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:	NCT00515606

Purpose

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

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease Bronchiolitis	Drug: helium:oxygen	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Baqiyatallah Medical Sciences University:

Primary Outcome Measures:

assess spirometry and hemodynamic measures after heliox or air:oxygen use

Study Start Date:	February 2007
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	38 Years to 59 Years
Genders Eligible for Study:	Male

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515606

Sponsors and Collaborators

Baqiyatallah Medical Sciences University

Investigators

Study Director:

Mostafa Ghanei, MD

Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University

More Information

No publications provided

Study ID Numbers:	210586
Study First Received:	August 13, 2007
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00515606 History of Changes
Health Authority:	Iran: Baqiyatallah Medical Sciences University

Study placed in the following topic categories:

Mustard Gas
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases
Mechlorethamine

Bronchiolitis
Lung Diseases
Respiration Disorders
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases

Bronchiolitis
Respiration Disorders
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 04, 2009