Oxygen Titration Strategies for Respiratory Insufficiency

(Oxygap pong Trial)

Recruiting at 1 trial location

Overseen By Pierre Alexandre Bouchard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: No SpO2 signal, Methemoglobinemia, Isolation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different oximeters (devices that measure blood oxygen levels) and oxygen targets affect oxygen flow needs in patients recovering from heart surgery. Researchers compare two types of oximeters, Nonin and Philips, with different oxygen targets to determine their influence on oxygen requirements. The trial suits individuals who have recently undergone heart surgery, are in intensive care, and are using oxygen therapy but still find normal breathing challenging. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance oxygen therapy for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these oxygen titration strategies are safe?

Research has shown that Nonin and Philips oximeters are generally safe and easy to use for checking blood oxygen levels. Studies indicate that the Nonin oximeter effectively detects low oxygen levels, identifying all moderate cases of hypoxemia. However, it might sometimes display lower oxygen levels than they actually are.

Philips oximeters, on the other hand, might slightly overestimate oxygen levels, especially in individuals with darker skin tones. Despite this, hospitals widely use and trust them. Both Nonin and Philips oximeters are non-invasive and commonly used, making them a reliable choice for safely monitoring oxygen levels. Studies have not reported any significant side effects from using these devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the oxygen titration strategies being tested because they aim to optimize oxygen delivery for patients with respiratory insufficiency. Unlike standard care, which often uses a fixed high-flow oxygen delivery, these methods adjust oxygen levels more precisely to maintain specific SpO2 targets of either 90% or 94% using Nonin and Philips oximeters. This personalized approach could potentially improve patient outcomes by minimizing the risks of over-oxygenation or under-oxygenation, which are common concerns with traditional oxygen therapy. The trial explores how these different devices and targets can be fine-tuned to provide the most effective and safe respiratory support.

What evidence suggests that this trial's oximeter strategies could be effective for respiratory insufficiency?

This trial will compare different oxygen titration strategies using two types of oximeters, the Nonin and Philips, each with specific SpO2 targets. Research has shown that the choice of oximeter and the set targets for blood oxygen levels can influence a patient's oxygen needs. Participants will be assigned to one of four groups: Nonin oximeter with a 90% SpO2 target, Nonin oximeter with a 94% SpO2 target, Philips oximeter with a 90% SpO2 target, or Philips oximeter with a 94% SpO2 target. The Nonin oximeter often reads blood oxygen levels lower than they are, allowing for a higher target with less oxygen needed. Studies suggest that maintaining blood oxygen levels between 90-94% is effective for many patients. The Philips oximeter is widely used in hospitals for monitoring breathing. Each oximeter offers distinct advantages: Nonin excels at detecting low oxygen levels, while Philips is known for accuracy across various healthcare settings. Selecting the appropriate oximeter and target can help tailor oxygen therapy to each patient. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are currently using oxygen therapy at a moderate flow with a nasal cannula, and your oxygen levels are between 88% and 100%.

Patients admitted to postoperative cardiac surgery intensive care unit

You have a specific tube in your artery for breathing support.

Exclusion Criteria

Your methemoglobin levels are higher than 0.015 on your most recent arterial blood gas test.

Your oxygen level cannot be measured with a special device called an oximeter.

False nails or nail polish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo four 10-minute periods of oxygenation target assessment using different oximeters and SpO2 targets

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nonin oximeter (SpO2 target 90%)
• Nonin oximeter (SpO2 target 94%)
• Philips oximeter (SpO2 target 90%)
• Philips oximeter (SpO2 target 94%)

Trial Overview 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.

How Is the Trial Designed?

Group I: Philips oximeter with a 94% SpO2 target Experimental Treatment 1 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 target Experimental Treatment 1 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 target Experimental Treatment 1 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 target Experimental Treatment 1 Intervention

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

Nonin oximeter (SpO2 target 90%) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nonin oximeter for:

• Monitoring of oxygen saturation (SpO2) in adult, pediatric, and neonatal patients

Approved in European Union as Nonin oximeter for:

• Monitoring of oxygen saturation (SpO2) in adult, pediatric, and neonatal patients

Approved in Canada as Nonin oximeter for:

• Monitoring of oxygen saturation (SpO2) in adult, pediatric, and neonatal patients

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

In a study of 54 critically ill patients, a pulse oximetry target of 92% SpO2 was found to be reliable for adjusting oxygen levels in white patients, indicating effective oxygenation.

However, for black patients, a higher SpO2 target of 95% was necessary to avoid significant hypoxemia, highlighting the need for tailored oxygenation strategies based on patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of pulse oximetry in titrating supplemental oxygen therapy in ventilator-dependent patients. Jubran, A., Tobin, MJ.[2022]

In a study analyzing over 27,000 pulse oximetry readings in newborns, it was found that peripheral oxygen saturation (SpO2) readings consistently overestimated arterial oxygen saturation (SaO2) by an average of 2.9%, which could lead to inaccurate oxygen titration.

The study revealed that in many cases, SpO2 readings did not accurately reflect critical arterial oxygen tension (PaO2) levels, indicating that pulse oximetry may not be reliable for guiding oxygen therapy in neonatal patients, especially when SpO2 values were below 91%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. Wackernagel, D., Blennow, M., Hellström, A.[2021]

Recent studies have identified potential cardiovascular toxicity and fatalities in monkeys after intravenous administration of phosphorothioate oligonucleotide drugs, raising safety concerns that must be addressed in clinical trial designs.

It is recommended that drug sponsors conduct thorough cardiovascular screening and research into the mechanisms of this toxicity to ensure safe dosing regimens for oligonucleotide therapies before initiating clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies. Black, LE., Farrelly, JG., Cavagnaro, JA., et al.[2019]

In a study involving 303 patients at Southampton Hospitals, pharmacist-led monitoring effectively identified 21 suspected adverse drug reactions (ADRs) associated with newly marketed drugs, demonstrating the feasibility of this approach in a hospital setting.

The study highlighted that while pharmacist monitoring was effective, the lack of electronic patient records (EPRs) limited efficiency; better-designed EPR systems could enhance the identification of patients on newly marketed drugs and improve monitoring outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. Emerson, A., Martin, RM., Tomlin, M., et al.[2016]

Adjusting the pulse oximeter alarm limits and goal range for oxygen saturation in premature infants did not significantly change the overall distribution of SpO2 values, as both groups spent similar amounts of time within, above, and below the target range.

However, the change in policy led to a significant increase in the time that SpO2 levels fell below 80% in the second group, indicating that such changes in monitoring protocols need careful evaluation to ensure the safety of vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? Laptook, AR., Salhab, W., Allen, J., et al.[2022]

The 'SIGNAL' publication from the Uppsala Monitoring Centre is considered timely and useful by 63.5% of respondents from 45 countries, indicating its significant role in addressing drug safety issues.

Actions based on the signals presented in 'SIGNAL' were taken by 17 countries in 2001, demonstrating that the publication directly influences drug safety practices among WHO Programme members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the impact of drug safety signals from the WHO database presented in 'SIGNAL': results from a questionnaire of National pharmacovigilance Centres. Ståhl, M., Edwards, IR., Bowring, G., et al.[2018]

The recommended target oxygen saturation (SpO2) range of 92-96% for oxygen therapy in adults without COPD may be more beneficial than the higher range of 94-98% suggested by the British Thoracic Society.

This conclusion is based on a review of available evidence, indicating that a lower target range could improve patient outcomes in specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target oxygen saturation range: 92-96% Versus 94-98. Beasley, R., Chien, J., Douglas, J., et al.[2018]

In a study involving 41 preterm infants receiving noninvasive respiratory support, narrowing the pulse oximetry target range during automated oxygen control significantly reduced the time spent in severe hypoxemia (SpO2 <80%) without increasing the risk of hyperoxemia.

All three target ranges (86%-94%, 88%-92%, and 89%-91%) allowed for similar time spent within the clinically set alarm limits, but the narrower ranges (88%-92% and 89%-91%) were more effective in preventing severe drops in oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Target Range of Closed-Loop Inspired Oxygen Support in Preterm Infants: A Randomized Cross-Over Study. van den Heuvel, MEN., van Zanten, HA., Bachman, TE., et al.[2019]

The safety profile of a drug post-registration is primarily informed by spontaneous reports from healthcare professionals, highlighting the importance of ongoing monitoring after a drug is approved.

This article focuses on analyzing adverse drug reactions reported to the Regional Centre of Monitoring Adverse Drug Reactions in Poznań, emphasizing the need for systematic evaluation of these reports to ensure drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. Jabłecka, A., Korzeniowska, K.[2013]

A total of 499 adverse drug reactions were reported under a voluntary reporting scheme, highlighting significant safety concerns such as life-threatening reactions to anti-inflammatory drugs and immediate hypersensitivity to anesthetics.

An additional 904 reactions were identified through an intensive survey in general practice, along with 342 from ongoing hospital monitoring, indicating a broad spectrum of drug reactions that require careful monitoring and analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Zealand Committee on Adverse Drug Reactions: eleventh annual report 1976. McQueen, EG.[2013]

In a study of 33 ventilator-dependent patients, pulse oximetry (SpO2) consistently overestimated arterial blood gas saturation (SaO2), indicating a need for careful evaluation of monitoring equipment before implementing nurse-directed protocols for oxygen titration.

The research suggests that a minimum SpO2 threshold of 96% is more reliable to ensure that SaO2 remains above 90%, highlighting the importance of accurate monitoring in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the need of bedside accuracy of pulse oximetry in an intensive care unit. Seguin, P., Le Rouzo, A., Tanguy, M., et al.[2019]

In a study of 31 patients with very severe COPD, titration methods based on constant work-rate tests provided better oxygen saturation (SpO2) maintenance (>90%) during daily activities compared to traditional methods like NOTT guidelines and walking tests.

The constant work-rate tests at 12 ml O2/min/kg resulted in significantly less time spent with SpO2 < 90% (6.7%) compared to the other methods, indicating a more effective approach for oxygen therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise oxygen flow titration methods in COPD patients with respiratory failure. Galera, R., Casitas, R., Martínez, E., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6594211/

Wearable Finger Pulse Oximetry for Continuous Oxygen ... This study used wearable finger pulse oximeters to continuously measure SpO 2 during daily home routines of COPD patients and assess natural SpO 2 fluctuations.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753597/

Impact of SpO2 Targets and Pulse Oximeter Brand ... The choice of the S pO 2 target has been shown to modulate oxygen flow, with an increase by >3-fold for 4% differences in S pO 2 targets.

3. publications.ersnet.org publications.ersnet.org/content/erj/62/suppl67/pa1040

Automated oxygen titration at home for patients with COPD SpO2 was in target interval (90-94 %) in 94.8 % of the time for patient 1 and 84.7 % of the time for patient 2. Oxygen flow was median 1.3 l/min (2.5-97.5 % ...

4. nonin.com nonin.com/wp-content/uploads/Open-Oximetry-Data-Clinical-Summary_Onyx-Vantage-9590-Pulse-Oximeter.pdf?srsltid=AfmBOoqiPndz02Fq3_37RUNgVx6LGwtwiLOF5vtz2EYvHOdR4J71isKT

Clinical Summary pigmentation and SpO2 levels between 80–90%, the Nonin Onyx Vantage 9590 had a bias of 0.8%. (95% CI 0.5, 1.2), which was lower than nine other devices tested.

5. thorax.bmj.com thorax.bmj.com/content/thoraxjnl/80/11/803.full.pdf

Optimised oxygenation improves functional capacity during ... time spent within acceptable SpO2- interval (SpO2 90–94%), time spent with moderate hypoxaemia (SpO2 85–89%) and with severe hypoxaemia (SpO2 ...

6. nonin.com nonin.com/technologies/pulse-oximetry/?srsltid=AfmBOopqxPgaz80mnnQK49c1cALNiFJXA4Ognw8nEWi7rWFm1ivRm7AN

Pulse Oximetry Nonin's pulse oximeters directly and accurately measure the amount of blood oxygen content quickly and easily with noninvasive devices.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6953261/

A multicentre prospective observational study comparing ... None of the participants with a SpO2 ≥ 92% were hypoxaemic, defined as SaO2 < 90%. There were no clinically significant differences in oximetry ...

8. fda.gov fda.gov/media/175828/download

FDA Executive Summary Performance Evaluation of Pulse ... Pulse oximeters are widely used by many types of healthcare providers and consumers to obtain an indirect measure (SpO2) of arterial blood ...

9. nonin.com nonin.com/wp-content/uploads/Open-Oximetry-Data-Clinical-Summary_Onyx-Vantage-9590-Pulse-Oximeter.pdf?srsltid=AfmBOoqw8Umyl0UXGF8D6p1UPT3c5UEa4c-h35nUtaF-UdSwilbqHn8I

Clinical Summary The risk of low cost and non-regulated devices reading inaccurately and potentially misdiagnosing hypoxemia in patients of color continues to be a problem.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10171338/

Accuracy of Multiple Pulse Oximeters in Stable Critically Ill ... The Nonin oximeter was the most sensitive of the 4 tested oximeters for detection of hypoxemia. It detected 100% of the states of moderate hypoxemia. On the ...