Oxygen Titration Strategies for Respiratory Insufficiency

(Oxygap pong Trial)

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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the idea that Oxygen Titration Strategies for Respiratory Insufficiency is an effective treatment?

The available research shows that using pulse oximetry to guide oxygen levels can be effective in managing respiratory insufficiency. For example, in ventilator-dependent patients, a target oxygen level of 92% was found to be reliable for white patients, while a higher target of 95% was needed for black patients to ensure proper oxygenation. This suggests that adjusting oxygen levels based on pulse oximetry readings can help maintain adequate oxygen levels in patients. Additionally, a study on preterm infants found that setting specific target ranges for oxygen levels helped keep them within a safe range, indicating the effectiveness of this treatment in different patient groups. ^{1 2 3 4 5}

What safety data exists for oxygen titration strategies using pulse oximeters?

The provided research does not contain specific safety data for oxygen titration strategies using pulse oximeters or related devices. The articles focus on adverse drug reactions, pharmacovigilance, and drug safety monitoring, which are not directly related to the safety of oxygen titration strategies or pulse oximeters. ^{6 7 8 9 10}

Is the treatment using Nonin and Philips oximeters with different SpO2 targets promising for respiratory insufficiency?

Yes, using Nonin and Philips oximeters to target specific SpO2 levels can be promising for managing oxygen levels in patients with respiratory insufficiency. These devices help ensure patients receive the right amount of oxygen, which is crucial for their health. By setting specific targets, healthcare providers can better control oxygen delivery, potentially improving patient outcomes. ^{1 2 3 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reliability of pulse oximetry in titrating supplemental oxygen therapy in ventilator-dependent patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Optimal Target Range of Closed-Loop Inspired Oxygen Support in Preterm Infants: A Randomized Cross-Over Study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence for the need of bedside accuracy of pulse oximetry in an intensive care unit. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Target oxygen saturation range: 92-96% Versus 94-98. [2018]

6. Poland pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. [2013]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies. [2019]

9. New Zealand 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. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Exercise oxygen flow titration methods in COPD patients with respiratory failure. [2013]

12. Norway pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. [2021]