Pulmonary DiseaseOXYMETRENCT03966196
Validation and Characterization of Signal Decrease on an Oximeter in COPD (They Have Chronic Obstructive Pulmonary Disease) Patients During Deep Inhalation (
A study testing Measurements of oxygen saturation and finger pressure during deep inspiration in people with Pulmonary Disease and Copd, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Copd
- What is being tested?
- Measurements of oxygen saturation and finger pressure during deep inspiration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2019to 10 May 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults volunteers are recruited from students with normal lung function.
- Adults with Chronic Obstructive pulmonary disease
Who cannot join
- abnormal lung function
- COPD Arm
- cardiovascular disease
- The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease
The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation
- Conditions
- Pulmonary Disease, Copd
- Being tested
- Measurements of oxygen saturation and finger pressure during deep inspiration
- Keywords
- COPD
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of oxygen saturation and finger pressure during deep inspirationOther
Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | oxymetry and finger pressure in Healthy subjects Receives: Other: Measurements of oxygen saturation and finger pressure during deep inspiration |
| COPD patients | Experimental | oxymetry and finger pressure in COPD patients Receives: Other: Measurements of oxygen saturation and finger pressure during deep inspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
drop in oxygen saturation during deep inspiration in COPD
saturation is measured in percentage (SPO2)
Measured: from the intervention to 3 minutes after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start11 Feb 2019
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- half healthy subject, half COPD patients
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Liistro, PhD, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966196
- Sponsor's protocol ID
- 2018/25AVR/185
- Acronym
- OXYMETRE
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Characterization of Signal Decrease on an Oximeter in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03966196
- Acronym / sponsor ID
- OXYMETRE / 2018/25AVR/185
- Conditions
- Pulmonary Disease, Copd
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 29 May 2019 (actual)
- 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.
The objective is to verify that there is a decrease in the pulsed oxygen saturation with the digital sensor. That is, the drop in oxygen saturation in COPD patients during inhalation is real and not due to an artifact of the measuring tool, because oximeters need a quality pulsatile signal to properly measure oxygen saturation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- half healthy subject, half COPD patients
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Other: Measurements of oxygen saturation and finger pressure during deep inspirationoxymetry and finger pressure in Healthy subjects |
| COPD patients | Experimental | Other: Measurements of oxygen saturation and finger pressure during deep inspirationoxymetry and finger pressure in COPD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults volunteers are recruited from students with normal lung function.
- Adults with Chronic Obstructive pulmonary disease
Key exclusion criteria (4 listed)
- abnormal lung function
- COPD Arm
- cardiovascular disease
- The subjects selected are selected on a voluntary basis among the patients coming to the pulmonary consultation. They have Chronic Obstructive Pulmonary Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of oxygen saturation and finger pressure during deep inspirationMeasurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff | Other | COPD patients, Healthy Volunteers |
Primary outcome
drop in oxygen saturation during deep inspiration in COPD
Time frame: from the intervention to 3 minutes after the start of the intervention
saturation is measured in percentage (SPO2)
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 29 May 2019.
- Individual participant dataSharing planned: No
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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.
Giuseppe Liistro, PhD, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of oxygen saturation and finger pressure during deep inspiration in people with Pulmonary Disease and Copd, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 4 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 29 May 2019. 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 Belgium. 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?
drop in oxygen saturation during deep inspiration in COPD (time frame: from the intervention to 3 minutes after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2019.