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

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD Exacerbation, Pneumonia, Hypoxemia, Respiratory Disease

Intervention / Treatment
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* Device: Masimo oximeter
* Device: Nellcor oximeter
* Device: Nonin oximeter


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen flow | 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 | 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 | 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 | 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 | the mean bias between the result of the different oximeter | assessed up to 10 minutes - until SpO2 target stability for 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen, oximeter