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

Primary Purpose

Cystic Fibrosis

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

physiotherapy

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, physiotherapy, pulmonary function test

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

CF patients over 7 years old

Exclusion Criteria:

Hemoptysis
Pregnancy

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

physiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Pulmonary function test

Secondary Outcome Measures

Full Information

NCT ID

NCT00908505

First Posted

May 19, 2009

Last Updated

May 26, 2009

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00908505

Brief Title

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

Acronym

RTX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic fibrosis, physiotherapy, pulmonary function test

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

physiotherapy

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

physiotherapy

Intervention Description

physiotherapy either by biphasic cuirass ventilator or physiotherapist

Primary Outcome Measure Information:

Title

Pulmonary function test

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CF patients over 7 years old Exclusion Criteria: Hemoptysis Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Shoseyov, MD

Phone

972-2-5844430

shoseyov@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Hadas Lemberg, PhD

Phone

972 2 6777572

lhadas@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Shoseyov, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91240

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Shoseyov, MD

Phone

972-2-5844430/1

shoseyov@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Malena Cohen-Cymberknoh, MD

12. IPD Sharing Statement

Learn more about this trial

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

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