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Electronic Optimization of Inspired Oxygen During Mechanical Ventilation, a Pragmatic Randomized Trial (OPTI-Oxygen)

NCT05923853 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2025-04-11

No results posted yet for this study

Summary

OPTI-Oxygen is a single center, stepped wedged, cluster-randomized, un-blinded, pragmatic, comparing the use of a combined inspired oxygen (FiO2) and peripheral oxygen saturation (SpO2) titration strategy utilizing electronic health records (EHR) based electronic alerts (e-alerts) for respiratory therapists in mechanically ventilated critically ill adults. All eligible mechanically ventilated patients, FiO2 titration and SpO2 goal range will be based on the correlation between SpO2 and arterial oxygen saturation (SaO2). E-alerts will be sent in the intervention arm as reminders for FiO2 titration. In the control arm, patients will have oxygen titrated per current standard of care (SpO2=88-92%, titrate FiO2 at least every 4 hours).

Conditions

  • Hyperoxia

Interventions

OTHER

FiO2 titration using electronic alert system

In the intervention arm, arterial oxygen saturation (SaO2) and peripheral oxygen saturation (SpO2) will be initially noted. Based on the correlation between the SaO2 and SpO2 the optimal oxygenation range will be determined. E-alerts will then be used to monitor oxygenation for patients in the intervention arm, based on SpO2 values generated by the patient due to the FiO2 given to the patient through the ventilator. Once an e-alert is sent, the respiratory therapist has 45 minutes for adjusting oxygen. Then the e-alert continues to monitor FiO2 and SpO2 values in this manner for every 45 minute period until the ventilator is attached to the patient.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-08-31
Completion
2026-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923853 on ClinicalTrials.gov