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

Sponsor

Baqiyatallah Medical Sciences University (Other)

Overall Status

Completed

CT.gov ID

NCT00642447

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Bronchiolitis Chronic Bronchitis	Drug: helium:oxygen mixture	Phase 2/Phase 3

Study Design

Study Type:

Interventional

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

Study Start Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: helium:oxygen mixture

Arm

Intervention/Treatment

Experimental: 1

Drug: helium:oxygen mixture

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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