Oxygen Therapy Interfaces for Respiratory Insufficiency

(Interfaces Trial)

Not yet recruiting at 1 trial location

Overseen By François Lellouche

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: False nails, Nail polish, Severe anemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 15 minutes per study period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different devices for delivering oxygen affect the flow rates needed for patients with breathing difficulties. Researchers aim to evaluate the effectiveness of these devices in controlling oxygen and carbon dioxide levels, particularly when using closed masks that might cause rebreathing. The study compares two types of oximeters, which track blood oxygen levels. This trial suits adults already using oxygen therapy who experience varying oxygen levels on their usual devices. As an unphased trial, it offers patients the opportunity to contribute to understanding and improving oxygen delivery methods.

Will I have to stop taking my current medications?

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

What prior data suggests that these oxygen therapy interfaces are safe for respiratory insufficiency?

Previous studies have shown that both the Nellcor and Nonin oximeters reliably monitor oxygen levels in patients. Tests of the Nellcor oximeter in various settings revealed a small average error of 0.57% for lower oxygen levels, indicating its accuracy in detecting blood oxygen. Research also highlights its dependable performance in hospitals.

The Nonin oximeter is similarly accurate, even in patients with weak pulses and breathing difficulties. It uses PureSAT technology to effectively track changes in oxygen levels. The FDA has reviewed both devices, confirming their widespread use and reliability in healthcare.

No major safety concerns have been reported for either device. Both are well-tolerated, meaning patients generally do not experience problems when using them. Their established use in healthcare suggests they are safe for further studies and trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how different oxygen therapy interfaces can be used to optimize oxygenation targets for patients with respiratory insufficiency. Unlike the standard nasal cannula or face mask, this trial compares devices like the Nellcor and Nonin oximeters to see if they can provide more precise monitoring and potentially better outcomes. The unique aspect of these devices is their ability to offer continuous, accurate oxygen saturation readings, which could help tailor oxygen delivery more effectively to each patient's needs. This could lead to better management of respiratory insufficiency by ensuring patients receive the right amount of oxygen, reducing the risk of complications from too much or too little oxygen.

What evidence suggests that these oxygen therapy interfaces are effective for respiratory insufficiency?

This trial will compare the effectiveness of different pulse oximeters in delivering oxygen therapy to patients with respiratory insufficiency. Research has shown that the Nellcor oximeter, one of the devices tested in this trial, provides quicker and more stable oxygen readings than some other devices, particularly for newborns. It detects low oxygen levels with 94.4% accuracy and normal levels with 83.1% accuracy. Meanwhile, the Nonin oximeter, another device under study, is known for its reliable use in home settings and is praised by healthcare providers for its efficiency. Both devices effectively check oxygen levels, which is crucial for adjusting oxygen therapy in patients with breathing problems. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with respiratory issues like insufficient oxygen levels, lung damage from too much oxygen, chronic bronchitis, COPD, or respiratory failure. Participants should need supplemental oxygen therapy.

Inclusion Criteria

SpO2 < 92% ambient air with the usual oximeter

I am on oxygen therapy and my oxygen levels are between 88% and 100%.

Exclusion Criteria

Oxygen flow > 6 L/min

No SpO2 signal with the usual oximeter

Presence of 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 are evaluated for the impact of different oxygen interfaces on oxygen flow rates and carbon dioxide levels

15 minutes per study period

Multiple study periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comparison of Several Oxygenation Targets with Different Oxygen Interfaces

Trial Overview The study tests how different oxygen delivery methods (open mask vs. nasal canula at various flow rates) affect the amount of oxygen a patient receives and their carbon dioxide levels.

How Is the Trial Designed?

Group I: Nonin Oximeter Experimental Treatment 1 Intervention

Group II: Nellcor oximeter Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

Oxygen therapy is crucial for treating respiratory insufficiency, particularly indicated by low levels of oxygen in the blood (PaO2), with specific thresholds defining absolute (PaO2 < 40 mm Hg), urgent (PaO2 < 30 mm Hg), and relative (PaO2 > 50 mm Hg) indications based on a study of 100 patients.

Using oxygen therapy when PaO2 is above 70 mm Hg or for preventive measures without hypoxemia can be harmful, and in cases where oxygen treatment is ineffective, mechanical ventilation should be considered, especially for patients in respiratory coma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications and contraindications for oxygen therapy of respiratory insufficiency]. Patarinski, D.[2009]

Citations

1. medtronic.com medtronic.com/covidien/en-gb/products/pulse-oximetry/clinical.html

Nellcor™ Pulse Oximetry Clinical Evidence Bibliography Nellcor™ Pulse Oximetry Clinical Studies - Review nearly 300 studies that highlight the benefits of Nellcor™ pulse oximetry in a wide variety of patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9269825/

Accuracy of a New Pulse Oximetry in Detection of Arterial ... Sensitivity for the ability of BrOxy M to detect Nellcor SpO2 ≤ 94% was 94.4%; specificity to detect normal saturation (SpO2 > 94%) was 83.1%; ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05790616

Accuracy of Pulse Oximeters During Profound Hypoxia This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test ...

4. journal.chestnet.org journal.chestnet.org/article/S0012-3692(16)32029-3/fulltext

Reliability of Pulse Oximetry in Titrating Supplemental Oxygen ... In white patients, we found that a SpO2 target of 92 percent was reliable in predicting a satisfactory level of oxygenation. However, in black patients, such a ...

5. prnewswire.com prnewswire.com/news-releases/new-study-in-newborns-finds-nellcor-pulse-oximetry-technology-provides-faster-stable-oxygen-saturation-readings-than-masimo-pulse-oximeter-301224405.html

New Study in Newborns Finds Nellcor™ Pulse Oximetry ... New Study in Newborns Finds Nellcor™ Pulse Oximetry Technology Provides Faster Stable Oxygen Saturation Readings Than Masimo Pulse Oximeter.

6. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/patient-monitoring/nellcor-pulse-oximetry-never-miss-a-beat-campaign-interactive-brochure.pdf

nellcor-pulse-oximetry-never-miss-a-beat- ... - Medtronic Please consult the IFU and manual for full safety information. Nellcor™ pulse oximetry has consistently delivered respiratory monitoring solutions that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367492/

A Comparison With Capnography - PMC These data demonstrate the performance of the Medtronic Nellcor Respiration Rate Software in healthy subjects and patients hospitalized in a low-acuity care ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07201961

Nellcor™ Abbreviated Sensor Additional Data Collection The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released ...

9. mdpi.com mdpi.com/1424-8220/22/13/5031

Accuracy of a New Pulse Oximetry in Detection of Arterial ... The mean bias for the subjects with Nellcor SpO2 ≤ 94% was 0.57%, with accuracy 3.0%, whereas corresponding figures for the subjects with Nellcor SpO2 ≤ 90% ...

10. 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 ...