Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ohio State University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Duration of Hyperoxemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
In this study providers cannot be masked, outcome assessors and investigators will be blinded
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Duration of Hyperoxemia
Time Frame: Duration of Mechanical Ventilation, an average of 10-14 days
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.
Secondary Outcomes
- 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)
Investigators
Sonal Pannu
Assistant Professor
Ohio State University