Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

NCT04481581 | Active Not Recruiting DMC

• 2 other identifiers: 2014H02365KL2TR002734-03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of Hyperoxemia

  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.

  Duration of Mechanical Ventilation, an average of 10-14 days

Secondary Outcomes (3)

• Ventilator Free days

  28 days

• ICU length of stay

  days of ICU stay within hospitalization, average of 20-25 days

• Duration of stay in the hospital after patient enrollment

  Current Hospital Stay, upto 30 days

Study Arms (2)

Intervention arm- Oxygen titration with electronic alerts

EXPERIMENTAL

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

Other: Electronic Alerts

Control Arm- Oxygen titration by one time physician orders

NO INTERVENTION

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

Interventions

Electronic Alerts 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.

Intervention arm- Oxygen titration with electronic alerts

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill subjects who require mechanical ventilation for at least 24 hours.

You may not qualify if:

• Subjects without research authorization,
• Pregnancy,
• Pneumothorax,
• Carbon monoxide poisoning,
• Hyperbaric oxygen therapy
• Acute ST elevation Myocardial Infarction

Sponsors & Collaborators

• Ohio State University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Pannu SR, Haddad T, Exline M, Christman JW, Horowitz JC, Peters J, Brock G, Diaz P, Crouser ED. Rationale and design of a randomized controlled clinical trial; Titration of Oxygen Levels (TOOL) during mechanical ventilation. Contemp Clin Trials. 2022 Aug;119:106811. doi: 10.1016/j.cct.2022.106811. Epub 2022 May 31.

  PMID: 35660485 DERIVED

Study Officials

• Sonal R Pannu, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study providers cannot be masked, outcome assessors and investigators will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 22, 2020
• Study Start: January 5, 2021
• Primary Completion: February 1, 2024
• Study Completion: October 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)