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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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Bronchiolitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

helium:oxygen

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

38 Years - 59 Years (Adult)Male

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00515606

First Posted

August 13, 2007

Last Updated

August 13, 2007

Sponsor

Baqiyatallah Medical Sciences University

1. Study Identification

Unique Protocol Identification Number

NCT00515606

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Baqiyatallah Medical Sciences University

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Bronchiolitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

helium:oxygen

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

38 Years

Maximum Age & Unit of Time

59 Years

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa Ghanei, MD

Organizational Affiliation

Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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