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NCT00908505 Clinical Trial

Comparison Between RTX (Biphasic Cuirass Ventilator) and Physiotherapy in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— RTX  

Official title:
Comparison Between bi-Phasic Negative Pressure Ventilator Therapy and Physiotherapy in Cystic Fibrosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00908505
Other study ID # RTX- HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 19, 2009
Last updated May 26, 2009
Start date July 2009
Est. completion date December 2011

Study information
Verified date May 2009
Source Hadassah Medical Organization
Contact David Shoseyov, MD
Phone 972-2-5844430
Email shoseyov@hadassah.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of different mucous clearance techniques in cystic fibrosis patients

Description:

Cystic fibrosis (CF) is associated with chronic progressive lung disease that may lead to respiratory failure.Bi-Phasic Cuirass Ventilation (BPCV) is a form of non-invasive respiratory support, which can provide negative pressure ventilation as well as high frequency chest wall oscillations and cough mode.The standard therapy for CF patients to release mucous is treatment by a physiotherapist. In this study we will compare the effect of BPCV with regular physiotherapy by full pulmonary function testing prior and post treatment.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 7 Years and older
Eligibility Inclusion Criteria:

- CF patients over 7 years old

Exclusion Criteria:

- Hemoptysis

- Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• physiotherapy
physiotherapy either by biphasic cuirass ventilator or physiotherapist

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary function test 1 hour No
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