Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD

Hôpital Universitaire Taher Sfar240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Acute Exacerbation of COPD

Interventions

Controlled oxygen therapyOTHER

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%.

Standard oxygen therapyOTHER

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%.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

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.

Time frame: From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization

Secondary Outcomes

Mortality at Day 28

Time frame: Day 28 after randomization

Length of stay in the intensive care unit

Time frame: From randomization until ICU discharge or death, up to 28 days

Requirement for invasive mechanical ventilation

Time frame: From randomization until ICU discharge or death