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Oxygen Titration Strategies for Respiratory Insufficiency (Oxygap pong Trial)
N/A
Recruiting
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Awards & highlights
Oxygap pong Trial Summary
This trial found that different oximeters provide different readings, and oxygen flow should take into account oximeter choice and SpO2 target.
Who is the study for?
Adults in postoperative cardiac surgery ICU on moderate oxygen therapy (up to 5L/min) with specific SpO2 levels, who have an arterial catheter and don't expect to change respiratory support within an hour. Excluded are those with certain blood conditions, no oximeter signal, nail coverings, or isolation due to infection.Check my eligibility
What is being tested?
The trial is testing how different oxygenation targets (90% vs. 94% SpO2) affect oxygen flow rates when using two types of oximeters (Philips and Nonin). It aims to determine if the target and device choice impact the amount of oxygen needed by patients.See study design
What are the potential side effects?
While not explicitly stated for this trial, potential side effects may include issues related to prolonged oxygen therapy such as dry or bloody nose, fatigue, morning headaches and in severe cases lung damage from high concentrations of oxygen.
Oxygap pong Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen flow (or FiO2)
Secondary outcome measures
Difference between SpO2 and SaO2
Other outcome measures
Complete oxygen weaning
Mean difference on oxymeter
Occult hyperoxemia
+3 moreOxygap pong Trial Design
4Treatment groups
Experimental Treatment
Group I: Philips oximeter with a 94% SpO2 targetExperimental Treatment1 Intervention
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.
Group II: Philips oximeter with a 90% SpO2 targetExperimental Treatment1 Intervention
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.
Group III: Nonin oximeter with a 94% SpO2 targetExperimental Treatment1 Intervention
During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.
Group IV: Nonin oximeter with a 90% SpO2 targetExperimental Treatment1 Intervention
During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.
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Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,232 Total Patients Enrolled
5 Trials studying Respiratory Failure
576 Patients Enrolled for Respiratory Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your methemoglobin levels are higher than 0.015 on your most recent arterial blood gas test.You are currently using oxygen therapy at a moderate flow with a nasal cannula, and your oxygen levels are between 88% and 100%.Your oxygen level cannot be measured with a special device called an oximeter.You are 18 years old or older.You have a specific tube in your artery for breathing support.Your blood oxygen level is below 92% when breathing normally, or it is below 92% when receiving a specific amount of oxygen.You are in isolation because you have specific bacteria or viruses, like C-Difficile or SARS-CoV-2, that can spread to others.You are likely to need additional breathing support within one hour of joining the study, such as a mask or high-flow oxygen, or to have a breathing tube removed within one hour of joining.
Research Study Groups:
This trial has the following groups:- Group 1: Nonin oximeter with a 94% SpO2 target
- Group 2: Philips oximeter with a 94% SpO2 target
- Group 3: Philips oximeter with a 90% SpO2 target
- Group 4: Nonin oximeter with a 90% SpO2 target
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment actively seeking volunteers?
"This investigation, which was initially posted on December 1st 2022, is no longer looking for candidates. As indicated by clinicaltrials.gov, the study has been inactive since October 18th 2022; however there are currently 178 different trials recruiting patients."
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