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

Sponsor
Laval University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05590130
Collaborator
(none)
12
1
4
12.9
0.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Manual Oxygen titration with Philips oximeter (SpO2 target 90%)
  • Device: Automated oxygen titration with Nonin oximeter (SpO2 target 90%)
  • Device: Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
  • Device: Automated oxygen titration with Nonin oximeter (SpO2 target 94%)
N/A

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.

During the Nonin periods, the adjustment of the oxygen flow rate will be performed automatically by the FreeO2, whereas during the Philips periods, 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nonin oximeter with a 90% SpO2 target

During this periods , oxygen will be administered in an automated titration with the FreeO2 device to reach 90% of SpO2.

Device: Automated oxygen titration with Nonin oximeter (SpO2 target 90%)
Oxygen titration to reach the SpO2 target (set at 90%) with Nonin oximeter

Experimental: Philips oximeter with a 90% SpO2 target

During this periods, oxygen will be adjusted manually, to reach 90% of SpO2.

Device: Manual Oxygen titration with Philips oximeter (SpO2 target 90%)
Oxygen titration to reach the SpO2 target (set at 90%) with Philips oximeter

Experimental: Nonin oximeter with a 94% SpO2 target

During this periods , oxygen will be administered in an automated titration with the FreeO2 device to reach 94% of SpO2.

Device: Automated oxygen titration with Nonin oximeter (SpO2 target 94%)
Oxygen titration to reach the SpO2 target (set at 94%) with Philips oximeter

Experimental: Philips oximeter with a 94% SpO2 target

During this periods, oxygen will be adjusted manually, to reach 94% of SpO2.

Device: Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
Oxygen titration to reach the SpO2 target (set at 94%) with Philips oximeter

Outcome Measures

Primary Outcome Measures

  1. Oxygen flow [Mean Oxygen flow in the last minute of each study period (between minute 9 and 10)]

    Oxygen flows at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oxymeter

Secondary Outcome Measures

  1. Difference between SpO2 and SaO2 [assessed up to 10 minutes - at the same of the arterial blood gases punction]

    Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)

Other Outcome Measures

  1. Mean difference on oxymeter [assessed up to 10 minutes - at the same of the arterial blood gases punction]

    Mean (±SD) of the gaps between the different oximeters tested

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥ 18 years of age

  • Patients admitted to postoperative cardiac surgery intensive care unit

  • Presence of an arterial catheter

  • 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.

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 ...)

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec Canada G1V4G5

Sponsors and Collaborators

  • Laval University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
François Lellouche, Principal investigator, Laval University
ClinicalTrials.gov Identifier:
NCT05590130
Other Study ID Numbers:
  • 22266
First Posted:
Oct 21, 2022
Last Update Posted:
Oct 21, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2022