Menu
Recruiting NCT05590130

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

No phase Interventional Oxygen Toxicity Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual Oxygen titration with Philips oximeter (SpO2 target 90%), Manual oxygen titration with Nonin oximeter (SpO2 target 90%), Manual Oxygen titration with Philips oximeter (SpO2 target 94%), Manual oxygen titration with Nonin oximeter (SpO2 target 94%).
Who it may be relevant to
Registry conditions: Oxygen Toxicity, Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).

Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.

At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.

The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.

Interventions

  • Device Manual Oxygen titration with Philips oximeter (SpO2 target 90%)
    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
  • Device Manual oxygen titration with Nonin oximeter (SpO2 target 90%)
    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
  • Device Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
  • Device Manual oxygen titration with Nonin oximeter (SpO2 target 94%)
    Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter

Primary outcome measures

  • Oxygen flow (or FiO2) [Time frame: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)]
Secondary outcome measures (1)
  • Difference between SpO2 and SaO2 [Time frame: assessed up to 10 minutes - at the same of the arterial blood gases punction]

Eligibility criteria

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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
  • Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec

Identifiers

NCT: NCT05590130 · 22266

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗