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

This study has been completed.

First Received: March 19, 2008 Last Updated: March 24, 2008 History of Changes

Sponsored by:	Baqiyatallah Medical Sciences University
Information provided by:	Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:	NCT00642447

Purpose

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.

Condition	Intervention	Phase
Bronchiolitis Chronic Bronchitis	Drug: helium:oxygen mixture	Phase II Phase III

MedlinePlus related topics: Bronchitis

Drug Information available for: Mechlorethamine Mechlorethamine hydrochloride Mustard gas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard

Further study details as provided by Baqiyatallah Medical Sciences University:

Estimated Enrollment:	23
Study Start Date:	April 2007

Arms	Assigned Interventions
1: Experimental	Drug: helium:oxygen mixture

Eligibility

Ages Eligible for Study:	38 Years to 59 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642447

Locations

Iran, Islamic Republic of
BMSU
Tehran, Iran, Islamic Republic of, 19945-546

Sponsors and Collaborators

Baqiyatallah Medical Sciences University

More Information

No publications provided

Study ID Numbers:	B12406
Study First Received:	March 19, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642447 History of Changes
Health Authority:	Iran: Baqiyatallah Medical Sciences University

Keywords provided by Baqiyatallah Medical Sciences University:

noninvasive ventilation
helium
oxygen

sulfur mustard
chronic bronchitis
bronchiolitis

Study placed in the following topic categories:

Mustard Gas
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases

Mechlorethamine
Lung Diseases
Bronchiolitis
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Bronchial Diseases
Bronchiolitis
Pharmacologic Actions
Bronchitis, Chronic
Mustard Gas
Lung Diseases, Obstructive
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases
Therapeutic Uses
Bronchitis
Dermatologic Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009