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NCT Number: NCT05819164

Comparison of Multiple Oxygenation Targets With Different Oximeters in Chronic Obstructive Pulmonary Disease (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.

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Key information

Conditions

COPD Exacerbation Hypoxemia Hypoxia Infections Lung Diseases Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Disease Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Masimo oximeter

Device

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

Nellcor oximeter

Device

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

Nonin oximeter

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 19, 2023
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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