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NCT00008775 Clinical Trial

Pressure Support Ventilation During CF Exacerbations

Cystic Fibrosis Clinical Trial

Official title:
Pressure Support Ventilation During CF Exacerbations: A Randomized, Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00008775
Other study ID # NCRR-M01RR00400-0654
Secondary ID
Status Suspended
Phase N/A
First received January 16, 2001
Last updated June 23, 2005

Study information
Verified date November 2001
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Chest physiotherapy is recognized as a mainstay of cystic fibrosis therapy, and is particularly important during treatment of pulmonary exacerbations. For some patients, especially those with moderate to severe compromise of lung function, this therapy may impose a high demand in the work of breathing and energy expenditure. The goal of this study is to evaluate the effectiveness of adding pressure support ventilation (PSV) during chest physiotherapy sessions in patients with cystic fibrosis with moderate to severe lung function compromise being treated for a pulmonary exacerbation.

Description:

The proposed study will be conducted over three years. Cystic fibrosis patients with moderate to severe pulmonary disease who are experiencing an acute exacerbation that requires hospitalization will be admitted to the GCRC. Subject participation in the study will be for the first 10 days of hospitalization. Subjects will be randomized into one of two treatment groups: usual care or usual care plus non-invasive pressure support ventilation (PSV).

Recruitment information / eligibility
Status Suspended
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 60 Years
Eligibility cystic fibrosis subjects with pulmonary exacerbation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Pressure support ventilation

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

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