Mechanical Ventilation
Conditions
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.
Interventions
OTHERElectronic 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Ohio State University
Study design
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
Intervention model description
This will be a parallel design, unblinded, randomized (1:1) trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hyperoxemia | 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
| Measure | Time frame | Description |
|---|---|---|
| Ventilator Free days | 28 days | The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment. |
| ICU length of stay | days of ICU stay within hospitalization, average of 20-25 days | Duration of stay in the intensive care unit after patient enrollment |
| Duration of stay in the hospital after patient enrollment | Current Hospital Stay, upto 30 days | Duration of stay in the hospital after patient enrollment |
Countries
United States
Outcome results
None listed