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

NCT ID: NCT00642447

Last Updated: 2008-03-25

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

PHASE2/PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiolitis Chronic Bronchitis

Keywords

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noninvasive ventilation helium oxygen sulfur mustard chronic bronchitis bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

helium:oxygen mixture

Intervention Type DRUG

Interventions

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helium:oxygen mixture

Intervention Type DRUG

Eligibility Criteria

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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
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

Locations

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BMSU

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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B12406

Identifier Type: -

Identifier Source: org_study_id