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

NCT ID: NCT00908505

Last Updated: 2009-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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physiotherapy

Group Type EXPERIMENTAL

physiotherapy

Intervention Type PROCEDURE

physiotherapy either by biphasic cuirass ventilator or physiotherapist

Interventions

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physiotherapy

physiotherapy either by biphasic cuirass ventilator or physiotherapist

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* CF patients over 7 years old

Exclusion Criteria

* Hemoptysis
* Pregnancy
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization, Jerusalem, Israel

Principal Investigators

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David Shoseyov, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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David Shoseyov, MD

Role: CONTACT

[email protected]
972-2-5844430

Hadas Lemberg, PhD

Role: CONTACT

[email protected]
972 2 6777572

Facility Contacts

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David Shoseyov, MD

Role: primary

[email protected]
972-2-5844430/1

Other Identifiers

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RTX- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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