- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00008775
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
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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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.
Collaborators
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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Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
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AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
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Clinical Trials on Pressure support ventilation
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Guy's and St Thomas' NHS Foundation TrustUnknownCOPD | Neuromuscular Disease | Chest Wall Disease | Obesity HypoventilationUnited Kingdom
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Centre Hospitalier Universitaire, AmiensCompletedCOPD Exacerbation | Weaning FailureFrance
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Centre Hospitalier Universitaire, AmiensWithdrawnNoctural Ventilatory Mode and Weaning DurationFrance
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Universidade Federal de PernambucoReal Hospital Português de Beneficência em PernambucoCompleted
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Postgraduate Institute of Medical Education and...CompletedChronic Obstructive Pulmonary Disease | Invasive Mechanical Ventilation | Adaptive Support VentilationIndia
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Assiut UniversityUnknown
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Izmir Dr Suat Seren Chest Diseases and Surgery...CompletedRespiratory Failure | All Intubated PatientsTurkey
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Massachusetts General HospitalMedtronic - MITGTerminatedRespiration, ArtificialUnited States
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University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompletedAcute Respiratory Distress SyndromeBrazil
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Cliniques universitaires Saint-Luc- Université...CompletedAcute Mechanical Ventilatory Failure | Psychosis Associated With Intensive CareBelgium