Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new system called O2matic PRO100, which automatically adjusts the amount of oxygen a patient receives to keep their blood oxygen levels within a healthy range (between 90-96% saturation) during the first 72 hours of a serious illness or injury. The goal is to see if this automated system works better than the traditional method where healthcare providers manually adjust oxygen levels based on their observations.

To participate in this trial, you need to be at least 18 years old and currently hospitalized for significant issues like major trauma, burns, or severe respiratory problems. You should also be receiving extra oxygen because your blood oxygen levels are low. If you’re interested in joining, you will need to give consent, either yourself or through a legally authorized representative. If you meet the criteria, you can expect to be randomly assigned to either receive oxygen management through the new system or the standard method. This study is important because finding more effective ways to manage oxygen can help improve recovery for patients facing critical conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness
• • Able to be randomized within 36 hours of hospital arrival
• • Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy)
• • Signed and dated informed consent from patient or legally authorized representative (LAR)
• Exclusion Criteria:
• • Anticipated hospital discharge within 24 hours
• • Imminent plans to discontinue supplemental oxygen
• • Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation
• • Clinical team unwilling or unable to follow the prescribed oxygen titration method in either randomized group
• • Known prisoner
• • Known pregnancy
• • Known contraindicated conditions for use of the PRO100 device: carbon monoxide poisoning, incapable of handling airway secretions, increased methemoglobin, cyanide poisoning, cluster headaches, undrained pneumothorax, sickle cell crisis, paraquat poisoning or a history of bleomycin poisoning, patients for whom the SpO2 signal is not stable