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

NCT05923853 | Suspended DMC

• 1 other identifier: 2023H0016
• Study Type: interventional
• Target: 936
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of time during mechanical ventilation spent within the target range, SpO2 of 90-94% (conservative) or SpO2 of 93-97% (liberal) at any FiO2 in respective algorithms.

  Percent time during mechanical ventilation in target range.

  through study completion, average of 28-30 days

Secondary Outcomes (10)

• Proportion of time with SpO2 > 94% or SpO2 > 97% with FiO2 ≤ 0.4 in respective algorithms.

  through study completion, average of 28-30 days

• Proportion of time with time with SpO2 < 90% or SpO2 < 93% in respective algorithms.

  through study completion, average of 28-30 days

• Length of ICU stay

  through study completion, average of 28-30 days

• Length of hospital stay

  through study completion, average of 28-30 days

• Hospital mortality

  through study completion, average of 28-30 days

Study Arms (2)

Oxygen (FiO2) Titration per E-alerts

EXPERIMENTAL

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.

Other: FiO2 titration using electronic alert system

Oxygen Titration per Standard of Care

NO INTERVENTION

In the control arm, patients will have oxygen titrated per current standard of care (SpO2=88-92%, titrate FiO2 at least every 4 hours). Physician place oxygen titration orders in EMR and respiratory therapists conduct FiO2 titration without electronic alerts.

Interventions

FiO2 titration using electronic alert system OTHER

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.

Oxygen (FiO2) Titration per E-alerts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Presence of mechanical ventilation

You may not qualify if:

• Pregnancy
• Prisoner status
• Pneumothorax
• Carbon monoxide poisoning
• Hyperbaric oxygen therapy

Sponsors & Collaborators

• Ohio State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Ohio State Wexner Medical Center

Columbus, Ohio, 43201, United States

Location

Related Publications (1)

• Pannu SR, Peters J, Zimmer J, Brock GN, Exline M, Horowitz JC, Thompson TB, Rice TW, Crouser ED. Optimization of Inspired Oxygen during Mechanical Ventilation (OPTI-OXYGEN): rationale and design of a pragmatic randomised controlled trial. BMJ Open. 2025 Jun 5;15(6):e094924. doi: 10.1136/bmjopen-2024-094924.

  PMID: 40473278 DERIVED

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Respiratory therapists and study coordinators will be unblinded. Study investigators, medical monitor and statistician will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 28, 2023
• Study Start: January 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: May 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after enrollment of the last patient. Data will be available for 5 years
• Access Criteria: To be determined

Locations

US (1)