Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of COPD, Intensive Care Unit (ICU), Controlled Oxygen Therapy, Mechanical Ventilation Complication
Conditions
Keywords
COPD; Acute exacerbation; Controlled oxygen therapy; Mechanical ventilation; Intensive care unit.
Brief summary
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.
Interventions
OTHERControlled oxygen therapy
Oxygen 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%.
Oxygen therapy will be administered according to the usual practice of the intensive care unit and adjusted to maintain peripheral oxygen saturation (SpO₂) above 94%.
Sponsors
Hôpital Universitaire Taher Sfar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of mechanical ventilation | From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization | Total cumulative duration of mechanical ventilation, defined as the sum of the duration of non-invasive ventilation and invasive mechanical ventilation. |
Secondary
| Measure | Time frame |
|---|---|
| Mortality at Day 28 | Day 28 after randomization |
| Length of stay in the intensive care unit | From randomization until ICU discharge or death, up to 28 days |
| Requirement for invasive mechanical ventilation | From randomization until ICU discharge or death |
Countries
Tunisia
Contacts
CONTACTHajer Nouira
Outcome results
None listed