Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

Mechanical Ventilation Clinical Trial

— TOOLs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481581
• Other study ID #: 2014H0236
• Secondary ID: 5KL2TR002734-03
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: Michelle Bright
• Phone: 614-292-3496
• Email: michelle.bright[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ventilator Free days	The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment.	28 days
Secondary	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
Secondary	Duration of stay in the hospital after patient enrollment	Duration of stay in the hospital after patient enrollment	Current Hospital Stay, upto 30 days