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

NCT ID: NCT00515606

Last Updated: 2007-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Interventions

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helium:oxygen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Principal Investigators

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Mostafa Ghanei, MD

Role: STUDY_DIRECTOR

Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University

Other Identifiers

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210586

Identifier Type: -

Identifier Source: org_study_id