- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303913
Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients
February 25, 2011 updated by: Villa Pineta Hospital
Composite Analysis on Factors That Predict Oxygen Desaturation During Walking in COPD
Oxygen desaturation (SO2 < 88-90%) during walking is a common clinical feature of Chronic Obstructive Pulmonary Disease (COPD) patients.
By a predicted analysis our study is aimed to evaluate anthropometric and functional characteristics of COPD patients correlated with oxygen desaturation during Six-minute walking test (6MWT).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
400
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
-
-
Modena
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Pavullo nel Frignano, Modena, Italy, 41026
- Villa Pineta Hospital
-
-
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
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
COPD patients
Description
Inclusion Criteria:
- COPD patients
- Ability to perform 6MWT
- Normal oxygen saturation at rest and at the begin of 6MWT
Exclusion Criteria:
- No-COPD patients
- Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
- Any co-morbidities
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Walking desaturation group
COPD patients that at the end of 6MWT have SO2 nadir <88-90%
|
|
Walking No-desaturation group
COPD patients that at the end of 6MWT have SO2 nadir >88-90%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen saturation nadir (SO2 nadir)
Time Frame: Measured at the end of 6MWT
|
Measured by change in percentage (%)
|
Measured at the end of 6MWT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ernesto Crisafulli, MD, PhD, Villa Pineta Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
June 1, 2010
Study Completion (ACTUAL)
February 1, 2011
Study Registration Dates
First Submitted
February 24, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (ESTIMATE)
February 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 28, 2011
Last Update Submitted That Met QC Criteria
February 25, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VP03-2010
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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