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Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation

Study acronym: Oxygap pong
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 30, 2024 to Dec 2026
    • Study completion date: Jun 30, 2025 to Jun 2027
    • Site details revised
    v5
  2. Primary completion date: Jun 30, 2023 to Dec 30, 2024
    • Study completion date: Dec 30, 2023 to Jun 30, 2025
    v4
  3. Interventions: Automated oxygen titration with Nonin oximeter (SpO2 target 90%) (Device), Automated oxygen titration with Nonin oximeter (SpO2 target 94%)… to Manual Oxygen titration with Philips oximeter (SpO2 target 90%) (Device), Manual Oxygen titration with Philips oximeter (SpO2 target 94%)…
    • Eligibility criteria revised
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 12 to 40
    • Primary endpoint revised
    • Start date changed from estimate of Dec 2022 to Nov 16, 2022
    • Eligibility criteria expanded, about 45 words
    • Study description shortened, about 23 words
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05590130
Lead Sponsor Laval University
Conditions
(from sponsor)		 Oxygen Toxicity, Respiratory Failure
Related terms Respiratory Insufficiency
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov