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Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (COPD) and Non-COPD Patients- Impact on Oxygen Flows

Comparison of Multiple Oxygenation Targets With Different Oximeters in COPD and Non-COPD Patients- Impact on Oxygen Flows

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05819164
Enrollment
40
Registered
2023-04-19
Start date
2023-05-25
Completion date
2025-09-25
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation, Hypoxemia, Pneumonia, Respiratory Disease

Keywords

oxygen, oximeter

Brief 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. 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.

Interventions

DEVICEMasimo oximeter

During this period, the Masimo oximeter Radical 7 was used for SpO2 reading

DEVICENellcor oximeter

During this period, the Nellcor oximeter N-600 was used for SpO2 reading

DEVICENonin oximeter

During this period, the Nonin oximeter was used for SpO2 reading

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Oxygen flowassessed up to 10 minutesthe mean oxygen flow to reach the SpO2 target +/- 1% during 2 minutes for each period and each oximeter

Secondary

MeasureTime frameDescription
Partial oxygen weaningassessed up to 10 minutes - until SpO2 target stability for 2 minutesRate of partial oxygen weaning (Oxygen flow \<=0.5 L/min) to reach the SpO2 target for each period and each oximeter
Complete oxygen weaningassessed up to 10 minutes - until SpO2 target stability for 2 minutesRate of complete oxygen weaning (Oxygen flow \<=0.1 L/min) to reach the SpO2 target for each period and each oximeter
High oxygen flowassessed up to 10 minutes - until SpO2 target stability for 2 minutesRate of high oxygen flow (Oxygen flow \>5.0 L/min) to reach the SpO2 target for each period and each oximeter
Oximeter bias comparisonassessed up to 10 minutes - until SpO2 target stability for 2 minutesthe mean bias between the result of the different oximeter

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026