Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators will conduct a prospective randomized, clinical trial in the Medical Intensive Care Unit at Ohio State University Medical Center. In the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. Oxygen titration in the control arm will be done without alerts and will be per current standard of care. Participants for this study will be identified and recruited from patients admitted to the Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive Care Unit.

Official Title
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Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Other: Electronic Alerts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Critically ill subjects who require mechanical ventilation for at least 24 hours. Exclusion Criteria: Subjects without research authorization, Pregnancy, Pneumothorax, Carbon monoxide poisoning, Hyperbaric oxygen therapy Acute ST elevation Myocardial Infarction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a parallel design, unblinded, randomized (1:1) trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm- Oxygen titration with electronic alerts<br>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 | Other: Electronic Alerts<br>* When FiO2 remains =>0.4 and SpO2 =>94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool.<br>|
| No Intervention: Control Arm- Oxygen titration by one time physician orders<br>Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hyperoxemia | The degree of excess exposure will be recorded as percent FiO2 >0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be exposed to excessive supplied oxygen divided by the total time under mechanical ventilation. | Duration of Mechanical Ventilation, an average of 10-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free days | The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment. | 28 days | 
| ICU length of stay | Duration of stay in the intensive care unit after patient enrollment | days of ICU stay within hospitalization, average of 20-25 days | 
| Duration of stay in the hospital after patient enrollment | Duration of stay in the hospital after patient enrollment | Current Hospital Stay, upto 30 days |