On-Demand Oxygen Therapy for Patient Monitoring

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Ards, Lung disease, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 1

Duration: Duration of the surgical procedure

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The main goal of this study is to determine if supplemental oxygen given only when the patient is inspiring (demand delivery) is more effective than constant-flow oxygen given during all phases of the breath regardless if the patient is breathing it in. A previous study in volunteers (NCT02886312) showed that the oxygen saturation in the blood and the concentration of oxygen breathed out from the lungs (end-tidal oxygen) was higher when given in demand (inhalation only) mode. A secondary goal is to determine in patients, whether turning oxygen delivery off during expiration improves the accuracy of end-tidal CO2 (Carbon Dioxide) monitoring. This was found to be the case in the previous volunteer study. The investigators want to determine if these improvements are also observable in relatively healthy patients undergoing procedural sedation and analgesia. The efficacy of the demand mode will be determined by measuring the resulting difference in oxygen saturation and end-tidal oxygen levels. The investigators will alternate between traditional oxygen delivery (continuous flow) and demand delivery (flow only during inhalation) for two minutes in each mode after which oxygen saturation and end-tidal oxygen will be measured. End-tidal CO2 measurement will be compared with those during the brief time when O2 flow is stopped.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the On Demand Oxygen Delivery System treatment?

Research shows that demand oxygen delivery systems (DODS) can improve oxygen delivery efficiency, saving oxygen and extending the time an oxygen cylinder can be used by 2- to 3-fold. These systems are particularly beneficial for patients with conditions like COPD and restrictive lung disease, as they enhance mobility and reduce the cost and waste associated with traditional continuous flow oxygen systems. ^{1 2 3 4 5}

Is on-demand oxygen therapy safe for humans?

Studies on demand oxygen delivery systems (DODS) suggest they are generally safe for use in humans, with some systems offering increased mobility and reduced oxygen usage. However, there are a few contraindications, such as for mouth breathers and during sleep, which should be considered. ^{1 2 6 7 8}

How does the On Demand Oxygen Delivery System treatment differ from traditional oxygen therapy?

The On Demand Oxygen Delivery System is unique because it delivers oxygen only when the patient inhales, which conserves oxygen and allows for greater mobility compared to traditional continuous oxygen delivery systems. This system can also automatically adjust oxygen flow based on the patient's needs, improving efficiency and potentially reducing costs. ^{1 2 6 7 9}

Research Team

Kai Kuck, Ph.D.

Principal Investigator

University of Utah Department of Anesthesiology

Eligibility Criteria

This trial is for relatively healthy patients undergoing sedation and pain relief during procedures, who are classified as ASA class I-III. It's not suitable for those with oxygen saturation below 93% on room air, severe lung or heart conditions, pregnant women, very high-risk surgery patients (ASA class IV+), short procedures under 20 minutes, or individuals under 18.

Inclusion Criteria

ASA class I-III

Exclusion Criteria

I have a history of severe lung or heart problems.

Pregnant women

My procedure is scheduled to last less than 20 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive alternating oxygen delivery modes (demand and continuous flow) during the surgical procedure

Duration of the surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• On Demand Oxygen Delivery System
• Oxygen Flow Stopped
• Traditional Oxygen Delivery System

Trial Overview The study tests if an 'on-demand' oxygen delivery system that provides oxygen only when a patient inhales is more effective than traditional continuous-flow systems. The effectiveness will be measured by blood oxygen levels and the accuracy of CO2 monitoring when the flow is stopped during exhalation.

Participant Groups

Group I: Only Arm Experimental Treatment 3 Interventions

Two minutes: Intervention: Device: On Demand Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Two minutes intervention: Device: Traditional, Always-On, Oxygen Delivery 20 sec or 3 breaths, whatever comes first: Intervention: Device: Oxygen Flow Stopped Repeat until the end of the surgical procedure

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

A study involving 26 patients with chronic respiratory conditions will compare a new portable oxygen concentrator with auto-demand oxygen delivery system (auto-DODS) to a conventional system, focusing on its effectiveness in maintaining oxygen saturation during rest and exercise.

The primary goal is to assess mean oxygen saturation levels, while secondary measures will evaluate the device's operational efficiency, patient comfort, and overall reliability, providing insights into the potential benefits of the auto-DODS in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized cross-over trial of demand oxygen delivery system. Nagano, T., Kobayashi, K., Omori, T., et al.[2022]

The use of Oxygen Alert Wristbands (OxyBands) significantly reduced inappropriate oxygen prescriptions in patients at risk of hypercapnic acidosis, indicating improved safety in oxygen therapy administration.

A majority of clinicians understood the risks associated with uncontrolled oxygen use, and 42 out of 44 patients found the OxyBands comfortable, suggesting they could be a more effective tool than traditional Oxygen Alert Cards for ensuring safe oxygen delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen alert wristbands (OxyBand) and controlled oxygen: a pilot study. Rickards, E., Wat, D., Kelly, CA., et al.[2020]

References

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

Comparison of two demand oxygen delivery devices for administration of oxygen in COPD. [2013]

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

Randomized cross-over trial of demand oxygen delivery system. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Controversial indications for long-term respiratory care: long-term oxygen therapy. [2016]

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

Demand oxygen delivery for patients with restrictive lung disease. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

Portable oxygen therapy with oxygen conserving devices and methodologies. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[Oxytron--ambulatory long-term oxygen therapy. Initial experiences with a new demand system for oxygen administration]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Home oxygen therapy: re-thinking the role of devices. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Oxygen alert wristbands (OxyBand) and controlled oxygen: a pilot study. [2020]

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

An inspiration-triggered delivery system for oxygen therapy via a nasal cannula. [2007]