Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts (TOOLs)

The Ohio State University

Status: Active, not recruiting

Conditions: Mechanical Ventilation

Treatments: Other: Electronic Alerts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04481581

2014H0236

5KL2TR002734-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Intervention arm- Oxygen titration with electronic alerts

Experimental group

Description:

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

Treatment:

Other: Electronic Alerts

Control Arm- Oxygen titration by one time physician orders

No Intervention group

Description:

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