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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve oxygen level management for patients on mechanical ventilation in intensive care. By using electronic alerts, the researchers aim to maintain optimal oxygen levels, avoiding both insufficient and excessive oxygen, which can be harmful. The trial will compare two methods: using electronic alerts for oxygen adjustment and following standard guidelines with one-time doctor orders. It targets individuals who are critically ill and require ventilation for more than a day.

As an unphased trial, it provides a unique opportunity to contribute to important research that could enhance patient care in critical 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.

What prior data suggests that this oxygen titration protocol with electronic alerts is safe?

Research has shown that using electronic alerts to manage oxygen levels during mechanical ventilation is generally safe. Studies have found that these alerts can adjust oxygen levels without causing harm. While specific data on negative effects from these studies is lacking, using electronic health records for oxygen adjustments appears well-tolerated. This suggests the process is unlikely to cause significant side effects in patients. Maintaining balanced oxygen levels is crucial, as both too little and too much oxygen can be harmful. This method aims to help maintain that balance safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel method for managing oxygen levels during mechanical ventilation using electronic alerts. Unlike the standard practice where oxygen titration is done based on one-time physician orders, this method employs real-time alerts and a decision support tool for respiratory therapists, potentially allowing for more precise and timely adjustments. This approach could lead to improved patient outcomes by ensuring oxygen levels are kept within optimal ranges more consistently.

What evidence suggests that electronic alerts for oxygen titration during mechanical ventilation are effective?

Research has shown that electronic alerts can effectively manage oxygen levels in patients on breathing machines. In this trial, participants in the intervention arm will receive oxygen titration based on these alerts, which have been proven to reduce both low oxygen levels (hypoxia) and high oxygen levels (hyperoxia). One study found that patients using this system had their oxygen therapy adjusted earlier, with 14.1% being taken off oxygen sooner compared to just 4.3% without it. This suggests that electronic alerts can manage oxygen more accurately, leading to better patient outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Sonal R Pannu, M.D.

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04481581

Study Details | NCT04481581 | Titration of Oxygen Levels ...

The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11114599/

Rationale and design of a randomized controlled clinical trial

This study is designed to evaluate the efficacy of a high fidelity, bioinformatics-based, electronic medical record derived electronic alert system to improve ...

3.

trialx.com

trialx.com/clinical-trials/listings/272500/titration-of-oxygen-levels-during-mechanical-ventilation-with-electronic-alerts/

Titration of Oxygen Levels During Mechanical Ventilation ...

The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen ...

4.

withpower.com

withpower.com/trial/phase-3-2021-3e06d

Electronic Alerts for Oxygen Levels During Mechanical ...

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 ...

5.

journals.lww.com

journals.lww.com/ccejournal/fulltext/2022/06000/early_titration_of_oxygen_during_mechanical.10.aspx

Early Titration of Oxygen During Mechanical Ventilation...

The primary end point was to determine if early Fio 2 titration based on automated alerts was feasible in terms of reducing hyperoxemia. Secondary analyses ...

6.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/record/NCT04481581

Titration of Oxygen Levels During Mechanical Ventilation With ...

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...