Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2025-10-01

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.

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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.

Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a parallel design, unblinded, randomized (1:1) trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

In this study providers cannot be masked, outcome assessors and investigators will be blinded

Study Groups

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Intervention arm- Oxygen titration with electronic alerts

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 Type EXPERIMENTAL

Electronic Alerts

Intervention Type OTHER

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.

Control Arm- Oxygen titration by one time physician orders

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic Alerts

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No