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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908505
Recruitment Status : Unknown
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 27, 2009
Last Update Posted : May 27, 2009
Information provided by:
Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Procedure: physiotherapy Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between bi-Phasic Negative Pressure Ventilator Therapy and Physiotherapy in Cystic Fibrosis Patients
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: physiotherapy Procedure: physiotherapy
physiotherapy either by biphasic cuirass ventilator or physiotherapist

Primary Outcome Measures :
  1. Pulmonary function test [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CF patients over 7 years old

Exclusion Criteria:

  • Hemoptysis
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908505

Contact: David Shoseyov, MD 972-2-5844430
Contact: Hadas Lemberg, PhD 972 2 6777572

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91240
Contact: David Shoseyov, MD    972-2-5844430/1   
Sub-Investigator: Malena Cohen-Cymberknoh, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: David Shoseyov, MD Hadassah Medical Organization

Responsible Party: Arik Tzukert, DMD, Hadassah Medical Organization, Jerusalem, Israel Identifier: NCT00908505     History of Changes
Other Study ID Numbers: RTX- HMO-CTIL
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009

Keywords provided by Hadassah Medical Organization:
Cystic fibrosis
pulmonary function test

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases