Oxygen Therapy Interfaces for Respiratory Insufficiency

(Interfaces Trial)

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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for respiratory insufficiency?

High-flow nasal oxygen therapy, a type of oxygen treatment, has been shown to improve oxygenation and reduce the risk of needing intubation in patients with acute respiratory failure. Additionally, using devices like the demand oxygen delivery system can efficiently deliver oxygen, potentially saving costs and improving patient comfort. ^{1 2 3 4 5}

Is oxygen therapy generally safe for humans?

Oxygen therapy is generally safe, but it can have side effects like nasal inflammation and risks associated with incorrect dosing, such as hyperoxemia (too much oxygen in the blood). Regular checks and proper use are important to ensure safety. ^{2 6 7 8 9}

How does the treatment in the Oxygen Therapy Interfaces for Respiratory Insufficiency trial differ from other treatments for respiratory insufficiency?

This treatment is unique because it compares different oxygenation targets using various oxygen delivery interfaces, potentially offering more personalized and effective oxygen therapy for patients with respiratory insufficiency. Unlike traditional methods, it may involve advanced microfluidic devices that improve oxygen delivery efficiency and safety by mimicking natural blood flow and reducing complications like clotting. ^{10 11 12 13 14}

What is the purpose of this trial?

Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive . The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective). secondary objective).

Eligibility Criteria

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

No SpO2 signal with the usual oximeter

Presence of false nails or nail polish

Oxygen flow > 6 L/min

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[High-flow nasal oxygen in acute hypoxemic respiratory failure]. [2022]

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

Validation of a novel device to objectively measure adherence to long-term oxygen therapy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Oxygen Reserve Index as a Tool to Monitor Four Techniques of Oxygen Supplementation at Different Flow Rates in Dogs Sedated with Dexmedetomidine and an Opioid. [2023]

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

Low-concentration oxygen therapy via a demand oxygen delivery system. [2019]

5. Bulgaria pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Nasal mucosa inflammation induced by oxygen administration in humans. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[German S3 Guideline - Oxygen Therapy in the Acute Care of Adult Patients]. [2022]

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

Noninvasive Oxygenation Strategies in Adult Patients With Acute Hypoxemic Respiratory Failure: A Systematic Review and Network Meta-Analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Home controls of a sample of 2,414 oxygen concentrators. Sous-Commission Technique ANTADIR. [2013]

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

Development of a biomimetic microfluidic oxygen transfer device. [2018]

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

Oxygen control: the often overlooked but essential piece to create better in vitro systems. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Designing a Microfluidic Device with Integrated Ratiometric Oxygen Sensors for the Long-Term Control and Monitoring of Chronic and Cyclic Hypoxia. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Generating linear oxygen gradients across 3D cell cultures with block-layered oxygen controlled chips (BLOCCs). [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Development and clinical application of a portable oxygen concentrator. [2004]