MedDataX Logo

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

NCT ID: NCT01303913

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD Oxygen desaturation Walking test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Walking desaturation group

COPD patients that at the end of 6MWT have SO2 nadir \<88-90%

No interventions assigned to this group

Walking No-desaturation group

COPD patients that at the end of 6MWT have SO2 nadir \>88-90%

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Villa Pineta Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Villa Pineta Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ernesto Crisafulli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Villa Pineta Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Villa Pineta Hospital

Pavullo nel Frignano, Modena, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Crisafulli E, Iattoni A, Venturelli E, Siscaro G, Beneventi C, Cesario A, Clini EM. Predicting walking-induced oxygen desaturations in COPD patients: a statistical model. Respir Care. 2013 Sep;58(9):1495-503. doi: 10.4187/respcare.02321. Epub 2013 Jan 29.

Reference Type DERIVED
PMID: 23362168 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VP03-2010

Identifier Type: -

Identifier Source: org_study_id