COPD ExacerbationNCT05819164
Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows
A study testing Masimo oximeter, Nellcor oximeter and Nonin oximeter in people with COPD Exacerbation and Pneumonia, run by Laval University at 1 site in Canada.
Trial summary
The oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Pneumonia, Hypoxemia
- What is being tested?
- Masimo oximeter, Nellcor oximeter and Nonin oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2023to 25 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- On conventional oxygen therapy with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% in ambient air with the usual oximeter
Who cannot join
- No availability of the SpO2 signal with the usual oximeter
- False nails or nail polish
- Severe anemia documented on the last blood count during the current hospitalization (Hb < 80g/L)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: Comparison of Multiple Oxygenation Targets With Different Oximeters in COPD and Non-COPD Patients- Impact on Oxygen Flows
The oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal.
The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.
- Conditions
- COPD Exacerbation, Pneumonia, Hypoxemia, Respiratory Disease
- Being tested
- Masimo oximeter, Nellcor oximeter, Nonin oximeter
- Keywords
- oxygen, oximeter
- Medical subject headings
- Pneumonia, Hypoxia, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo oximeterDevice
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Nellcor oximeterDevice
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Nonin oximeterDevice
During this period, the Nonin oximeter was used for SpO2 reading
| Study group | Role | What they receive |
|---|---|---|
| 88% SpO2 target | Experimental | During this periods , oxygen will be administered in manual titration to reach 88% of SpO2. Receives: Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter |
| 90% SpO2 target | Experimental | During this periods , oxygen will be administered in manual titration to reach 90% of SpO2. Receives: Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter |
| 92% SpO2 target | Experimental | During this periods , oxygen will be administered in manual titration to reach 92% of SpO2. Receives: Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter |
| 94% SpO2 target | Experimental | During this periods , oxygen will be administered in manual titration to reach 94% of SpO2. Receives: Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter |
| 96% SpO2 target | Experimental | During this periods , oxygen will be administered in manual titration to reach 96% of SpO2. Receives: Device: Masimo oximeter; Device: Nellcor oximeter; Device: Nonin oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen flow
the mean oxygen flow to reach the SpO2 target +/- 1% during 2 minutes for each period and each oximeter
Measured: assessed up to 10 minutes
Secondary outcomes (4)
Partial oxygen weaning
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) to reach the SpO2 target for each period and each oximeter
Measured: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Complete oxygen weaning
Rate of complete oxygen weaning (Oxygen flow <=0.1 L/min) to reach the SpO2 target for each period and each oximeter
Measured: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
High oxygen flow
Rate of high oxygen flow (Oxygen flow >5.0 L/min) to reach the SpO2 target for each period and each oximeter
Measured: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Oximeter bias comparison
the mean bias between the result of the different oximeter
Measured: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start25 May 2023
- Primary completion5 Dec 2024
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819164
- Sponsor's protocol ID
- 2023-4002
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2023
- Last updated
- 9 Mar 2026
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multiple Oxygenation Targets With Different Oximeters in COPD and Non-COPD Patients- Impact on Oxygen Flows
- ClinicalTrials.gov ID
- NCT05819164
- Acronym / sponsor ID
- 2023-4002
- Conditions
- COPD Exacerbation, Pneumonia, Hypoxemia, Respiratory Disease
- Keywords
- oxygen, oximeter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 19 Apr 2023 (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 oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal.
The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 88% SpO2 target | Experimental | Device: Masimo oximeter, Device: Nellcor oximeter, Device: Nonin oximeterDuring this periods , oxygen will be administered in manual titration to reach 88% of SpO2. |
| 90% SpO2 target | Experimental | Device: Masimo oximeter, Device: Nellcor oximeter, Device: Nonin oximeterDuring this periods , oxygen will be administered in manual titration to reach 90% of SpO2. |
| 92% SpO2 target | Experimental | Device: Masimo oximeter, Device: Nellcor oximeter, Device: Nonin oximeterDuring this periods , oxygen will be administered in manual titration to reach 92% of SpO2. |
| 94% SpO2 target | Experimental | Device: Masimo oximeter, Device: Nellcor oximeter, Device: Nonin oximeterDuring this periods , oxygen will be administered in manual titration to reach 94% of SpO2. |
| 96% SpO2 target | Experimental | Device: Masimo oximeter, Device: Nellcor oximeter, Device: Nonin oximeterDuring this periods , oxygen will be administered in manual titration to reach 96% of SpO2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- On conventional oxygen therapy with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 < 92% in ambient air with the usual oximeter
Key exclusion criteria (3 listed)
- No availability of the SpO2 signal with the usual oximeter
- False nails or nail polish
- Severe anemia documented on the last blood count during the current hospitalization (Hb < 80g/L)
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 |
|---|---|---|
| Masimo oximeterDuring this period, the Masimo oximeter Radical 7 was used for SpO2 reading | Device | 88% SpO2 target, 90% SpO2 target, 92% SpO2 target, 94% SpO2 target, 96% SpO2 target |
| Nellcor oximeterDuring this period, the Nellcor oximeter N-600 was used for SpO2 reading | Device | 88% SpO2 target, 90% SpO2 target, 92% SpO2 target, 94% SpO2 target, 96% SpO2 target |
| Nonin oximeterDuring this period, the Nonin oximeter was used for SpO2 reading | Device | 88% SpO2 target, 90% SpO2 target, 92% SpO2 target, 94% SpO2 target, 96% SpO2 target |
Primary outcome
Oxygen flow
Time frame: assessed up to 10 minutes
the mean oxygen flow to reach the SpO2 target +/- 1% during 2 minutes for each period and each oximeter
4 secondary outcomes
Partial oxygen weaning
Time frame: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Complete oxygen weaning
Time frame: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
High oxygen flow
Time frame: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Oximeter bias comparison
Time frame: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
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 9 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo oximeter, Nellcor oximeter and Nonin oximeter in people with COPD Exacerbation and Pneumonia, run by Laval University at 1 site in Canada.
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 9 Mar 2026. 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 Canada. 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 flow (time frame: assessed up to 10 minutes). 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 9 Mar 2026.