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Electronic Alerts for Oxygen Levels During Mechanical Ventilation (TOOLs Trial)

N/A
Recruiting
Led By Sonal R Pannu, M.D.
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Critically ill subjects who require mechanical ventilation for at least 24 hours
Be older than 18 years old
Must not have
Pneumothorax
Hyperbaric oxygen therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days of icu stay within hospitalization, average of 20-25 days
Awards & highlights

Summary

This trial will establish if an electronically guided protocol for adjusting oxygen levels can improve patient outcomes in the ICU.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves monitoring and adjusting existing treatments rather than testing new medications, side effects may relate more to potential errors in oxygen levels such as hypoxia (low oxygen) or hyperoxia (high oxygen).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a ventilator for at least 24 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a collapsed lung.
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I am receiving hyperbaric oxygen therapy.
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I have suffered from carbon monoxide poisoning.
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I have had a recent heart attack.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days of icu stay within hospitalization, average of 20-25 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and days of icu stay within hospitalization, average of 20-25 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of Hyperoxemia
Secondary outcome measures
Duration of stay in the hospital after patient enrollment
ICU length of stay
Ventilator Free days

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention arm- Oxygen titration with electronic alertsExperimental Treatment1 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 ordersActive Control1 Intervention
Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
844 Previous Clinical Trials
639,209 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
329 Previous Clinical Trials
401,854 Total Patients Enrolled
Sonal R Pannu, M.D.Principal InvestigatorOhio State University

Media Library

Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts Clinical Trial Eligibility Overview. Trial Name: NCT04481581 — N/A
Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts 2023 Treatment Timeline for Medical Study. Trial Name: NCT04481581 — N/A
Mechanical Ventilation Clinical Trial 2023: Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts Highlights & Side Effects. Trial Name: NCT04481581 — N/A
Mechanical Ventilation Research Study Groups: Intervention arm- Oxygen titration with electronic alerts, Control Arm- Oxygen titration by one time physician orders
~67 spots leftby Jul 2025
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