Electronic Alerts for Oxygen Levels During Mechanical Ventilation

(TOOLs Trial)

Overseen By Michelle Bright

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Pneumothorax, Myocardial infarction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10-14 days

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. Oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.

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 the treatment Electronic Alerts for Oxygen Levels During Mechanical Ventilation?

Research shows that using electronic alerts to manage oxygen levels during mechanical ventilation can improve patient safety by reducing excessive oxygen exposure and ensuring timely oxygen regulation. Automated systems for oxygen titration have been found to keep oxygen levels within target ranges more effectively than manual methods, which can lead to better patient outcomes. ^{1 2 3 4 5}

Is the use of electronic alerts for oxygen levels during mechanical ventilation safe for humans?

Research suggests that using electronic alerts to manage oxygen levels during mechanical ventilation is generally safe. Studies have shown that these alerts can help improve patient safety by reducing excessive oxygen exposure and preventing potential harm from unnoticed ventilator events. ^{1 2 3 6 7}

How does the treatment 'Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts' differ from other treatments for managing oxygen levels in mechanically ventilated patients?

This treatment is unique because it uses electronic alerts to help respiratory therapists adjust oxygen levels more precisely and quickly, improving patient safety by preventing excessive or insufficient oxygen exposure during mechanical ventilation. ^{1 2 3 8 9}

Research Team

Sonal R Pannu, M.D.

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for critically ill patients needing mechanical ventilation for at least a day. It's not suitable for those without research authorization, with conditions like pneumothorax, carbon monoxide poisoning, recent severe heart attacks or those undergoing hyperbaric oxygen therapy or who are pregnant.

Inclusion Criteria

I have been on a ventilator for at least 24 hours.

Exclusion Criteria

I have had a collapsed lung.

I am receiving hyperbaric oxygen therapy.

You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Oxygen titration using electronic alerts and decision support tool in the intervention arm, and standard care in the control arm

10-14 days

Continuous monitoring in ICU

Follow-up

Participants are monitored for ventilator-free days and ICU length of stay

28 days

Hospital Stay

Monitoring of duration of stay in the hospital after patient enrollment

up to 30 days

Treatment Details

Interventions

• Electronic Alerts
• Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Trial Overview The study tests an electronic alert system designed to help adjust the level of oxygen given to patients on mechanical ventilators. The goal is to find the right balance and avoid too much or too little oxygen which can be harmful.

Participant Groups

Group I: Intervention arm- Oxygen titration with electronic alerts Experimental Treatment 1 Intervention

Oxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=\> 0.4 and SpO2 =\>94% for more than 45 minutes

Group II: Control Arm- Oxygen titration by one time physician orders Active Control 1 Intervention

Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

In a pilot study involving 135 adults on mechanical ventilation, the use of automated electronic alerts for early titration of oxygen (Fio2) significantly reduced exposure to hyperoxemia by a median of 7.5 hours compared to standard care.

The intervention also led to a reduction in the duration of mechanical ventilation and ICU length of stay, while only a small percentage of alerts (12%) were associated with minor hypoxemic events, indicating a safe and effective approach to oxygen management in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Titration of Oxygen During Mechanical Ventilation Reduces Hyperoxemia in a Pilot, Feasibility, Randomized Control Trial for Automated Titration of Oxygen Levels. Pannu, SR., Exline, M., Klamer, B., et al.[2023]

In a study of 187 patients requiring oxygen therapy, automated closed-loop titration significantly improved the time spent within target oxygen saturation levels (81% vs. 51% for manual titration), indicating better adherence to treatment guidelines.

Automated titration also reduced the prevalence of hypoxaemia and hyperoxia, allowed for earlier weaning of oxygen in 14.1% of patients compared to 4.3% in the manual group, and decreased the duration of oxygen therapy during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic versus manual oxygen administration in the emergency department. L'Her, E., Dias, P., Gouillou, M., et al.[2022]

An electronic algorithm was developed to monitor ventilator settings in real-time, alerting healthcare providers to potentially harmful settings, which was tested on 1,159 patients in intensive care units.

After implementing the alert system, the average exposure to potentially injurious ventilation settings significantly decreased from 40.6 hours to 26.9 hours, indicating improved safety in ventilator care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. Herasevich, V., Tsapenko, M., Kojicic, M., et al.[2010]

This systematic review and meta-analysis aims to evaluate the effectiveness and safety of closed-loop oxygen control systems for managing hypoxaemia in hospitalized patients, focusing on primary outcomes like time spent within target oxygen saturation levels.

The study will analyze various secondary outcomes, including oxygen weaning time, length of hospital stay, costs, adverse events, and healthcare professionals' workload, to determine the overall impact of this technology on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop oxygen control for patients with hypoxaemia during hospitalisation: a living systematic review and meta-analysis protocol. Mol, CG., Vieira, AGDS., Garcia, BMSP., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Enhanced notification of critical ventilator events. [2019]

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

Early Titration of Oxygen During Mechanical Ventilation Reduces Hyperoxemia in a Pilot, Feasibility, Randomized Control Trial for Automated Titration of Oxygen Levels. [2023]

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

Electronic Medical Record-Based Pager Notification Reduces Excess Oxygen Exposure in Mechanically Ventilated Subjects. [2023]

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

Clinical Trial of an Educational Program to Decrease Monitor Alarms in a Medical Intensive Care Unit. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Automatic versus manual oxygen administration in the emergency department. [2022]

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

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. [2010]

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

Closed-loop oxygen control for patients with hypoxaemia during hospitalisation: a living systematic review and meta-analysis protocol. [2022]

8. Belgium pubmed.ncbi.nlm.nih.gov

Recent experience with a respiratory monitoring system in intensive care. [2006]

9. China pubmed.ncbi.nlm.nih.gov

[Research on Patient Monitoring Alarms in ICU and NICU]. [2021]