Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention...

Area of Science:

• Critical Care Medicine
• Respiratory Therapy
• Clinical Trials

Background:

• Supplemental oxygen is crucial for hypoxemia prevention in hospitalized patients.
• Current practices often lead to hyperoxemia and oxygen wastage due to excessive administration.
• Closed-loop autonomous oxygen titration systems aim to optimize oxygen delivery within a target range.

Purpose of the Study:

• To determine if closed-loop autonomous oxygen titration safely increases time in normoxemia (SpO2 90%-96%) in hospitalized adults.
• To compare autonomous oxygen titration with usual care in managing oxygen therapy.
• To evaluate the safety and efficacy of automated oxygen delivery systems.

Main Methods:

• A multicenter, unblinded, parallel-group, randomized trial involving 300 adults.
• Comparison of an autonomous oxygen titration system against usual care.
• Primary outcome: proportion of patient-time spent in normoxemia (SpO2 90%-96%) within the first 72 hours.

Main Results:

• The study is currently enrolling patients, with results to be disseminated upon completion.
• Key secondary outcomes include time spent in hypoxemia and hyperoxemia, and total oxygen administered.
• The trial protocol and statistical analysis plan have been finalized to ensure rigor.

Conclusions:

• The trial aims to provide crucial evidence on the effectiveness and safety of autonomous oxygen titration systems.
• Findings will inform clinical practice regarding optimal oxygen management in acute care settings.
• This research addresses a significant gap in understanding automated oxygen therapy for hospitalized patients.