Pressure Support Ventilation During CF Exacerbations

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

cystic fibrosis subjects with pulmonary exacerbation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Cystic Fibrosis Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 16, 2001

First Submitted That Met QC Criteria

January 17, 2001

First Posted (Estimate)

January 18, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00400-0654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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