Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Oxygap pong
1 other identifier
interventional
40
1 country
1
Brief Summary
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences. The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter. NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 4, 2025
August 1, 2025
4 years
October 14, 2022
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygen flow (or FiO2)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Secondary Outcomes (1)
Difference between SpO2 and SaO2
assessed up to 10 minutes - at the same of the arterial blood gases punction
Other Outcomes (6)
Mean difference on oxymeter
assessed up to 10 minutes - at the same of the arterial blood gases punction
Occult hypoxemia
assessed up to 10 minutes - at the same of the arterial blood gases punction
Occult hyperoxemia
assessed up to 10 minutes - at the same of the arterial blood gases punction
- +3 more other outcomes
Study Arms (4)
Nonin oximeter with a 90% SpO2 target
EXPERIMENTALDuring this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.
Philips oximeter with a 90% SpO2 target
EXPERIMENTALDuring this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.
Nonin oximeter with a 94% SpO2 target
EXPERIMENTALDuring this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.
Philips oximeter with a 94% SpO2 target
EXPERIMENTALDuring this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.
Interventions
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Patients admitted to postoperative cardiac surgery intensive care unit
- Presence of an arterial catheter Specific for the extubate patient
- Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- SpO2 \< 92% ambient air Specific for the intubate patient FiO2 \<= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 \< 92% with FiO2 0.21
You may not qualify if:
- No SpO2 signal with oximeter in use
- False nails or nail polish
- Methemoglobinemia \>0.015 on last available arterial gas
- Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 21, 2022
Study Start
November 16, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share