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

March 5, 2026 updated by: François Lellouche, Laval University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 88% SpO2 target
During this periods , oxygen will be administered in manual titration to reach 88% of SpO2.
Device: Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Device: Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Device: Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 90% SpO2 target
During this periods , oxygen will be administered in manual titration to reach 90% of SpO2.
Device: Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Device: Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Device: Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 92% SpO2 target
During this periods , oxygen will be administered in manual titration to reach 92% of SpO2.
Device: Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Device: Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Device: Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 94% SpO2 target
During this periods , oxygen will be administered in manual titration to reach 94% of SpO2.
Device: Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Device: Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Device: Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading
Experimental: 96% SpO2 target
During this periods , oxygen will be administered in manual titration to reach 96% of SpO2.
Device: Masimo oximeter
During this period, the Masimo oximeter Radical 7 was used for SpO2 reading
Device: Nellcor oximeter
During this period, the Nellcor oximeter N-600 was used for SpO2 reading
Device: Nonin oximeter
During this period, the Nonin oximeter was used for SpO2 reading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
assessed up to 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial oxygen weaning
Time Frame: assessed up to 10 minutes - until SpO2 target stability for 2 minutes
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) to reach the SpO2 target for each period and each oximeter
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
Rate of complete oxygen weaning (Oxygen flow <=0.1 L/min) to reach the SpO2 target for each period and each oximeter
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
Rate of high oxygen flow (Oxygen flow >5.0 L/min) to reach the SpO2 target for each period and each oximeter
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
the mean bias between the result of the different oximeter
assessed up to 10 minutes - until SpO2 target stability for 2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

September 25, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-4002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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