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

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ClinicalTrials.gov Identifier: NCT00642447
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : March 25, 2008
Sponsor:
Information provided by:
Baqiyatallah Medical Sciences University

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Chronic Bronchitis Drug: helium:oxygen mixture Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Study Start Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: helium:oxygen mixture




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Ages Eligible for Study:   38 Years to 59 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642447


Locations
Iran, Islamic Republic of
BMSU
Tehran, Iran, Islamic Republic of, 19945-546
Sponsors and Collaborators
Baqiyatallah Medical Sciences University

ClinicalTrials.gov Identifier: NCT00642447     History of Changes
Other Study ID Numbers: B12406
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008

Keywords provided by Baqiyatallah Medical Sciences University:
noninvasive ventilation
helium
oxygen
sulfur mustard
chronic bronchitis
bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Mechlorethamine
Mustard Gas
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Dermatologic Agents