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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642447
First Posted: March 25, 2008
Last Update Posted: March 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baqiyatallah Medical Sciences University
  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 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baqiyatallah Medical Sciences University:

Estimated Enrollment: 23
Study Start Date: April 2007
Arms Assigned Interventions
Experimental: 1 Drug: helium:oxygen mixture

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00642447     History of Changes
Other Study ID Numbers: B12406
First Submitted: March 19, 2008
First Posted: March 25, 2008
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:
Mechlorethamine
Mustard Gas
Bronchiolitis
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Dermatologic Agents