Helium:Oxygen Noninvasive Positive Pressure Ventilation i... | NCT00642447

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

NCT00642447

Sponsor

Baqiyatallah Medical Sciences University

Status

Completed

Last Update Posted

Mar 25, 2008Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Bronchiolitis
Chronic Bronchitis

Interventions

helium:oxygen mixture

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 19, 2008

First Submission Date that Met QC Criteria

Mar 24, 2008

First Posted Date

Mar 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2008

Last Update Posted Date

Mar 25, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Label	Type	Description	Intervention Names
1	Experimental		Drug: helium:oxygen mixture

Name	Type	Description	Arm Group Labels	Other Names
helium:oxygen mixture	Drug		1

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
BMSU		Tehran	Tehran Province	19945-546	Iran

Condition Browse Module

MeSH Terms

ID	Term
D001988	Bronchiolitis
D029481	Bronchitis, Chronic

Ancestor Terms

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

Browse Leaves

Not provided

Browse Branches

Not provided