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Clinical Trials/NCT04481581
NCT04481581
Active, Not Recruiting
N/A

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

Ohio State University1 site in 1 country300 target enrollmentJanuary 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Ohio State University
Enrollment
300
Locations
1
Primary Endpoint
Duration of Hyperoxemia
Status
Active, Not Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2021
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sonal Pannu

Assistant Professor

Ohio State University

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

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)

Study Sites (1)

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