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

Primary Purpose

Oxygen Toxicity, Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
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%)
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxygen Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut Universitaire de Cardiologie et de Pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Nonin oximeter with a 90% SpO2 target

Philips oximeter with a 90% SpO2 target

Nonin oximeter with a 94% SpO2 target

Philips oximeter with a 94% SpO2 target

Arm Description

During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.

During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.

During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.

During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2022
Last Updated
May 8, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT05590130
Brief Title
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Acronym
Oxygap pong
Official Title
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Toxicity, Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nonin oximeter with a 90% SpO2 target
Arm Type
Experimental
Arm Description
During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.
Arm Title
Philips oximeter with a 90% SpO2 target
Arm Type
Experimental
Arm Description
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.
Arm Title
Nonin oximeter with a 94% SpO2 target
Arm Type
Experimental
Arm Description
During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.
Arm Title
Philips oximeter with a 94% SpO2 target
Arm Type
Experimental
Arm Description
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.
Intervention Type
Device
Intervention Name(s)
Manual Oxygen titration with Philips oximeter (SpO2 target 90%)
Intervention Description
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter
Intervention Type
Device
Intervention Name(s)
Manual oxygen titration with Nonin oximeter (SpO2 target 90%)
Intervention Description
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter
Intervention Type
Device
Intervention Name(s)
Manual Oxygen titration with Philips oximeter (SpO2 target 94%)
Intervention Description
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Intervention Type
Device
Intervention Name(s)
Manual oxygen titration with Nonin oximeter (SpO2 target 94%)
Intervention Description
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter
Primary Outcome Measure Information:
Title
Oxygen flow (or FiO2)
Description
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
Time Frame
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Secondary Outcome Measure Information:
Title
Difference between SpO2 and SaO2
Description
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)
Time Frame
assessed up to 10 minutes - at the same of the arterial blood gases punction
Other Pre-specified Outcome Measures:
Title
Mean difference on oxymeter
Description
Mean (±SD) of the gaps between the different oximeters tested
Time Frame
assessed up to 10 minutes - at the same of the arterial blood gases punction
Title
Occult hypoxemia
Description
Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%)
Time Frame
assessed up to 10 minutes - at the same of the arterial blood gases punction
Title
Occult hyperoxemia
Description
Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%)
Time Frame
assessed up to 10 minutes - at the same of the arterial blood gases punction
Title
Partial oxygen weaning
Description
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min)
Time Frame
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Title
Complete oxygen weaning
Description
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)
Time Frame
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Title
Respiratory support escalation
Description
Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60)
Time Frame
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francois Lellouche
Phone
418656-8711
Ext
3572
Email
francois.lellouche@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Alexandre Bouchard
Phone
418656-8711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
Facility Information:
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Lellouche
Email
francois.lellouche@criucpq.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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