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NCT Number: NCT04481581

Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mechanical Ventilation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Alerts

Other

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.

Primary outcomes

  1. 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

  1. Ventilator Free days

    Time frame: 28 days

    The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment.

  2. ICU length of stay

    Time frame: days of ICU stay within hospitalization, average of 20-25 days

    Duration of stay in the intensive care unit after patient enrollment

  3. Duration of stay in the hospital after patient enrollment

    Time frame: Current Hospital Stay, upto 30 days

    Duration of stay in the hospital after patient enrollment

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: TOOLs

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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