Education for Low Oxygen Levels

Overseen By Carrie Higgins, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Transferred patients, Chronic ventilation, Pregnancy, Prisoners

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of ICU stay

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an educational program designed to help healthcare teams manage oxygen levels in ICU patients on ventilators. The goal is to maintain oxygen levels within a specific range, potentially reducing the time patients need ventilators and preventing hidden low oxygen levels. Patients currently in an ICU and requiring a ventilator may qualify for this trial. Virtual respiratory therapists provide real-time feedback to medical staff to ensure oxygen targets are met. As an unphased trial, this study allows patients to contribute to improving ICU care practices.

Do I need to stop my current medications to join the trial?

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 educational intervention is safe?

Research has shown that a combined educational approach to managing oxygen levels is generally safe. In one study, healthcare providers adjusted oxygen levels based on SpO2, which measures blood oxygen, ensuring patients received the correct amount of oxygen.

Another study found that when doctors followed specific guidelines for oxygen levels, they managed oxygen therapy safely. This method was well-received and did not cause major safety problems, with no reports of serious side effects directly linked to the educational approach itself.

Overall, previous research supports the safety of this method, demonstrating its effectiveness in managing oxygen levels without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multimodal educational intervention for managing low oxygen levels because it offers a novel approach that focuses on education and real-time feedback. Unlike standard treatments that primarily center around adjusting oxygen delivery devices, this intervention empowers clinical teams with specific target ranges for oxygen (SpO2 90-96%) and provides instant feedback from virtual respiratory therapists. This method could improve adherence to oxygen targets and optimize patient outcomes more effectively than current practices. By integrating education and technology, this intervention aims to enhance the precision and effectiveness of oxygen therapy.

What evidence suggests that this educational intervention is effective for reducing ventilator length of stay and occult hypoxemia?

Studies have shown that a combined educational approach can effectively help manage oxygen levels in patients. In this trial, participants will receive a Multimodal Educational Intervention to maintain oxygen levels within target ranges. Research indicates that keeping oxygen levels normal can reduce the need for extra oxygen without increasing the risk of low oxygen levels or death. One study successfully used educational methods to help healthcare teams maintain safe oxygen levels, reducing both high oxygen levels and unnecessary oxygen use. This approach provides real-time feedback to doctors and nurses, facilitating the achievement of oxygen goals and potentially shortening the time patients need to be on ventilators. This method has proven safe and beneficial in critical care settings. ^{3 4 5 6 7}

Who Is on the Research Team?

Neil Aggarwal, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for patients in the ICU who need machines to help them breathe. They're looking at whether educating healthcare staff about oxygen levels can help these patients.

Inclusion Criteria

I am in the ICU and on a breathing machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Educational Intervention

Standardized education and materials are provided to local stakeholders for hospital and ICU-level implementation, including virtual respiratory therapist-directed real-time feedback on adherence to the SpO2 target range.

2 weeks

Virtual sessions

Treatment

Implementation of the targeted oxygen saturation (SpO2) range of 90-96% in adult patients receiving mechanical ventilation using a multimodal educational intervention strategy.

Duration of ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking ICU free days, hospital free days, and ventilator free days.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Educational Intervention

Trial Overview The study tests if training ICU teams to keep patient's oxygen saturation between 90-96% can shorten the time on ventilators and prevent low oxygen levels without being noticed.

How Is the Trial Designed?

Group I: Educational intervention Experimental Treatment 1 Intervention

SP02 target ranges will be 90-96%. Education about the specific oxygen targets will be provided to the clinical teams. Real time feedback on adherence to the Sp02 target range will be provided by virtual respiratory therapists.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831952

Targeted Normoxemia and Supplemental Oxygen–Free ... The findings indicate that targeting normoxemia can safely reduce supplemental oxygen use without affecting mortality or time spent in hypoxemia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9709909/

A quasiexperimental study of targeted normoxia in critically ... This multimodal intervention strategy to target normoxia successfully reduced the probability of being hyperoxic and on supplemental oxygen in critically ill ...

3. researchgate.net researchgate.net/publication/390342486_Targeted_Normoxemia_and_Supplemental_Oxygen-Free_Days_in_Critically_Injured_Adults_A_Stepped-Wedge_Cluster_Randomized_Clinical_Trial

Targeted Normoxemia and Supplemental Oxygen–Free ... We used a multimodal informatics and educational intervention guiding clinicians to safely titrate supplemental oxygen to normoxia based on SpO2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9961389/

Effectiveness of Intermittent Hypoxia–Hyperoxia Therapy in ... Research conducted in 1939–1943 showed that even a small height improves pulmonary ventilation and increases hemoglobin concentration and oxygen saturation.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125001108

Evaluating the SWIFT algorithm's efficacy in predicting ... This study presents the process of applying a hypoxemia prediction model to additional public databases, highlighting the difficulties this external validation ...

6. digitalcommons.sacredheart.edu digitalcommons.sacredheart.edu/cgi/viewcontent.cgi?article=1048&context=dnp_projects

Oxygen Therapy Education to Improve Oxygen Safety in the ... Low oxygen level can lead to organ failure and death. Excessive ... An education intervention done earlier in 2022 increased the rate to 69% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12310998/

Knowledge, attitudes, and practices of oxygen therapy ... This cross-sectional study aimed to evaluate the knowledge, attitudes, and practices (KAP) regarding oxygen therapy among emergency nurses ...