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

Respiratory Failure Clinical Trial

— Oxygap pong  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590130
• Other study ID #: 22266
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: Francois Lellouche
• Phone: 418656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oxygen Toxicity
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean difference on oxymeter	Mean (±SD) of the gaps between the different oximeters tested	assessed up to 10 minutes - at the same of the arterial blood gases punction
Other	Occult hypoxemia	Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%)	assessed up to 10 minutes - at the same of the arterial blood gases punction
Other	Occult hyperoxemia	Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%)	assessed up to 10 minutes - at the same of the arterial blood gases punction
Other	Partial oxygen weaning	Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Other	Complete oxygen weaning	Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Other	Respiratory support escalation	Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60)	Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Primary	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	Difference between SpO2 and SaO2	Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter)	assessed up to 10 minutes - at the same of the arterial blood gases punction