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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00908505
First received: May 19, 2009
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention
Cystic Fibrosis
Procedure: physiotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between bi-Phasic Negative Pressure Ventilator Therapy and Physiotherapy in Cystic Fibrosis Patients

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Pulmonary function test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: physiotherapy Procedure: physiotherapy
physiotherapy either by biphasic cuirass ventilator or physiotherapist

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CF patients over 7 years old

Exclusion Criteria:

  • Hemoptysis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908505

Contacts
Contact: David Shoseyov, MD 972-2-5844430 shoseyov@hadassah.org.il
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91240
Contact: David Shoseyov, MD    972-2-5844430/1    shoseyov@hadassah.org.il   
Sub-Investigator: Malena Cohen-Cymberknoh, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David Shoseyov, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Arik Tzukert, DMD, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00908505     History of Changes
Other Study ID Numbers: RTX- HMO-CTIL
Study First Received: May 19, 2009
Last Updated: May 26, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on July 26, 2014