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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.
Sponsor:
Information provided by:
Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:
NCT00515606
First received: August 13, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Resource links provided by NLM:

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

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

Additional relevant MeSH terms:
Bronchiolitis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
 Respiratory Insufficiency
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013