Evaluating Closed-Loop Oxygen Control Compared to Manual Oxygen Titration in Intubated Critically Ill Adults

What this Trial Is About

Researchers are investigating the use of closed-loop oxygen control compared to manual oxygen titration in critically ill patients who are intubated and mechanically ventilated due to hypoxemic acute respiratory failure. The study aims to see if automatic oxygen management can improve oxygen delivery by keeping patients within an optimal oxygen saturation range. This single-blind, randomized crossover clinical trial assesses the efficacy and safety of these two oxygen administration methods. Participants will be randomly assigned to receive either closed-loop oxygen control using the HAMILTON-C6 ventilator with O2 Assist software or manual oxygen titration by clinicians. Each treatment period lasts 4 hours, during which oxygen levels are adjusted either automatically based on continuous SpO2 measurements or manually according to preset target ranges. The crossover design means each patient experiences both methods in separate periods. Throughout the study, researchers will record clinical and respiratory data, including ventilator parameters like FiO2 and SpO2, using a memory box connected to the ventilator. The main outcome is the percentage of time spent within optimal and sub-optimal SpO2 ranges during each 4-hour period. Secondary measures include time spent outside target ranges, frequency of manual adjustments, oxygen usage, alarms, and oxygen saturation below critical thresholds. This helps evaluate which method better maintains safe oxygen levels in critically ill patients.

Closed Loop Oxygen Control in INtubated Critically Ill Patients