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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oxygen delivery method that flows only when inhaling, rather than continuously. Researchers aim to determine if this method, called the On Demand Oxygen Delivery System, improves blood oxygen levels and enhances the accuracy of carbon dioxide monitoring during medical procedures. Participants will alternate between the new and traditional oxygen delivery methods to assess effectiveness. The trial seeks relatively healthy individuals undergoing procedures requiring sedation, without serious lung or heart conditions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance oxygen delivery in medical settings.

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 prior data suggests that this on-demand oxygen delivery system is safe for patient monitoring?

Research has shown that the On Demand Oxygen Delivery System can help patients. One study found that this system improved oxygen levels in people with breathing problems. It is safe for home use and carries a low risk of complications.

Traditional oxygen delivery systems are also generally safe. Studies have indicated that providing oxygen after surgery can prevent low oxygen levels. However, excessive oxygen during surgery might lead to risks such as lung or heart issues.

Overall, both oxygen delivery systems have been used safely in various situations. The On Demand System may offer benefits in managing oxygen levels more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the On Demand Oxygen Delivery System because it offers a smarter way to provide oxygen during surgical procedures. Unlike traditional systems that deliver a constant flow of oxygen, this system delivers oxygen only when needed—either for 20 seconds or after 3 breaths, whichever comes first. This approach helps conserve oxygen, reduce waste, and potentially improve patient comfort by avoiding unnecessary oxygen exposure. The trial aims to demonstrate how this method could lead to more efficient and personalized oxygen delivery during surgeries.

What evidence suggests that the On Demand Oxygen Delivery System is effective for improving oxygen saturation and end-tidal oxygen levels?

Research has shown that a demand oxygen delivery system, which provides oxygen only during inhalation, can improve blood oxygen levels. One study found that this method increased both the oxygen in the blood and the oxygen exhaled. This system has also effectively treated low blood oxygen levels (hypoxemia) at rest and during exercise.

In this trial, participants will use both the demand oxygen delivery system and the traditional oxygen delivery system, which provides a constant oxygen flow. Traditional systems are often used to prevent low oxygen levels after surgery, but studies have shown they might not always improve outcomes like reducing infections or breathing problems. The demand system could offer a more efficient way to deliver oxygen when needed most. ^{3 6 7 8 9}

Who Is on the Research Team?

Kai Kuck, Ph.D.

Principal Investigator

University of Utah Department of Anesthesiology

Are You a Good Fit for This Trial?

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

I am under 18 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127411/

Feasibility of continuous non-invasive delivery of oxygen ... We demonstrated a novel proof-of-concept and feasibility of continuous, real-time, non-invasive DO 2 monitoring, with each patient serving as their own control.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7220698/

Randomized cross-over trial of demand oxygen delivery ... Long-term oxygen therapy is reported to improve hypoxemia and survival in patients with respiratory failure. The demand oxygen delivery ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(16)39909-3/fulltext

Performance of a Demand Oxygen Saver System during Rest ... Demand oxygen systems have been shown to be effective in treating hypoxemia during seated rest and during exercise, but the performance of these systems ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/05080/randomized_cross_over_trial_of_demand_oxygen.39.aspx

Randomized cross-over trial of demand oxygen delivery... Long-term oxygen therapy (LTOT) is reported to improve hypoxemia and survival and has become an essential treatment for patients with respiratory failure caused ...

5. digitalcommons.usu.edu digitalcommons.usu.edu/cgi/viewcontent.cgi?article=1462&context=spacegrant

Testing an Oxygen Demand Delivery Device This study has shown that our intelligent oxygen flowmeter can obtain end-tidal oxygen and pulse oxygen saturation values equivalent to or higher than ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11865769/

Optimising timely and safe oxygen delivery systems for ... This study demonstrated a significant increase in timely and safe oxygen delivery from 30% to 75% through a multifaceted approach that included ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1470211824029518

Outcomes from a virtual ward delivering oxygen at home ... Provision of oxygen at home for selected patients recovering from COVID-19 is safe with low risk of readmission and death.

8. nature.com nature.com/articles/s41746-024-01182-w

A systematic review of the impacts of remote patient ... RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and ...

9. nature.com nature.com/articles/s41598-025-87665-6

Smart oxygen monitoring in hospitals: a pilot study during ... This study aimed to develop and test a smart monitoring system to detect increased oxygen concentrations in hospital environments, mitigating the risk of fires.