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

Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Other: Electronic Alerts

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Bright; Phone Number: 614-292-3496; Email: michelle.bright@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Medical Center
      • Contact: Sonal Pannu; Phone Number: 507-226-1636; Email: sonal.pannu@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm- Oxygen titration with 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	Other: Electronic Alerts; 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.
No Intervention: Control Arm- Oxygen titration by one time physician orders; Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Sonal R Pannu, M.D., Ohio State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2014H0236; 5KL2TR002734-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No