Clinical trial NCT04481581: Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts
Official title: Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel design, unblinded, randomized (1:1) trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Hyperoxemia
timeFrame: Duration of Mechanical Ventilation, an average of 10-14 days
Secondary outcomes:
measure: Ventilator Free days
timeFrame: 28 days
measure: ICU length of stay
timeFrame: days of ICU stay within hospitalization, average of 20-25 days
measure: Duration of stay in the hospital after patient enrollment
timeFrame: Current Hospital Stay, upto 30 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Sonal R Pannu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.