About this trial
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Acute exacerbations frequently require intensive care unit (ICU) admission. Oxygen therapy is an essential component of treatment; however, excessive oxygen administration may aggravate hypercapnia and respiratory acidosis. Current international guidelines recommend titrated oxygen therapy targeting an oxygen saturation of 88-92% in patients with acute exacerbation of COPD, but evidence supporting this strategy in critically ill ICU patients remains limited. This randomized controlled trial aims to compare a controlled oxygen therapy strategy (target oxygen saturation 88-92%) with standard oxygen therapy (oxygen saturation \>94%) in ICU patients admitted with acute exacerbation of COPD. The primary objective is to determine whether controlled oxygen therapy reduces the duration of mechanical ventilation (invasive and non-invasive). Secondary objectives include assessing the 28-day mortality, ICU length of stay, the need for invasive mechanical ventilation, and adverse events related to hyperoxia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years
Established diagnosis of chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
Admission to the intensive care unit for an acute exacerbation of COPD, with or without respiratory acidosis
Written informed consent provided by the participant or their legally authorized representative
Disqualifiers
Endotracheal intubation performed before enrollment
Severe decompensated heart failure with a left ventricular ejection fraction < 30%
Active terminal malignancy
Refusal to participate in the study
Trial design
Parallel
Treatments tested in this trial
Controlled oxygen therapy
Other interventionOxygen therapy will be administered using an adjustable oxygen delivery device, including nasal cannula, Venturi mask, or high-flow nasal oxygen, and titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%.
Standard oxygen therapy
Other interventionOxygen therapy will be administered according to the usual practice of the intensive care unit and adjusted to maintain peripheral oxygen saturation (SpO₂) above 94%.
Treatment groups
Trial outcomes
Primary outcomes
Total duration of mechanical ventilation
Total cumulative duration of mechanical ventilation, defined as the sum of the duration of non-invasive ventilation and invasive mechanical ventilation.
Secondary outcomes
Mortality at Day 28
Length of stay in the intensive care unit
Requirement for invasive mechanical ventilation
Sponsors and contacts
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