Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Not Applicable

Active, not recruiting

• Conditions: Mechanical Ventilation
• Interventions: Other: Electronic Alerts

• Registration Number: NCT04481581
• Lead Sponsor: Ohio State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2021-01-05
• Primary Completion: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm- Oxygen titration with electronic alerts	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

Primary Outcome Measures

Name	Time	Method
Duration of Hyperoxemia	Duration of Mechanical Ventilation, an average of 10-14 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States