COPDNCT01303913
Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of COPD, run by Villa Pineta Hospital at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- COPD patients
- Ability to perform 6MWT
- Normal oxygen saturation at rest and at the begin of 6MWT
Who cannot join
- No-COPD patients
- Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
- Any co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- COPD
- Keywords
- COPD, Oxygen desaturation, Walking test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation nadir (SO2 nadir)
Measured by change in percentage (%)
Measured: Measured at the end of 6MWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ernesto Crisafulli, MD, PhD, Principal investigator, Villa Pineta Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303913
- Sponsor's protocol ID
- VP03-2010
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23362168
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Analysis on Factors That Predict Oxygen Desaturation During Walking in COPD
- ClinicalTrials.gov ID
- NCT01303913
- Acronym / sponsor ID
- VP03-2010
- Conditions
- COPD
- Keywords
- COPD, Oxygen desaturation, Walking test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (3 listed)
- COPD patients
- Ability to perform 6MWT
- Normal oxygen saturation at rest and at the begin of 6MWT
Key exclusion criteria (3 listed)
- No-COPD patients
- Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
- Any co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygen saturation nadir (SO2 nadir)
Time frame: Measured at the end of 6MWT
Measured by change in percentage (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
- Derived from this study: PubMed 23362168Crisafulli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto Crisafulli, MD, PhD principal investigator
Villa Pineta Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Villa Pineta Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation nadir (SO2 nadir) (time frame: Measured at the end of 6MWT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2011.