Text Size

Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by:
Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT01303913
First received: February 24, 2011
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
  Purpose

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).


Condition
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Composite Analysis on Factors That Predict Oxygen Desaturation During Walking in COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • Oxygen saturation nadir (SO2 nadir) [ Time Frame: Measured at the end of 6MWT ] [ Designated as safety issue: No ]
    Measured by change in percentage (%)


Enrollment: 400
Study Start Date: June 2010
Study Completion Date: February 2011
Groups/Cohorts
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%

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

COPD patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303913

Locations
Italy
Villa Pineta Hospital
Pavullo nel Frignano, Modena, Italy, 41026
Sponsors and Collaborators
Villa Pineta Hospital
Investigators
Principal Investigator: Ernesto Crisafulli, MD, PhD Villa Pineta Hospital
  More Information

No publications provided

Responsible Party: Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01303913     History of Changes
Other Study ID Numbers: VP03-2010
Study First Received: February 24, 2011
Last Updated: February 25, 2011
Health Authority: Italy: Villa Pineta Fundation Review Board

Keywords provided by Villa Pineta Hospital:
COPD
Oxygen desaturation
Walking test

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013