Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Total duration of mechanical ventilation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Controlled oxygen therapy group
Controlled oxygen therapy group: Oxygen will be administered using an adjustable delivery device (nasal cannula, Venturi mask, or heated high-flow humidified oxygen) to maintain an Sp-92% oxygen saturation (SpO-92%).
干预措施: Controlled oxygen therapy (Other)
Standard oxygen therapy group:
Standard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ >94%.
干预措施: Standard oxygen therapy (Other)
结局指标
主要结局
Total duration of mechanical ventilation
时间窗: 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.
次要结局
- 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)
研究者
Hajer Nouira
Associate Professor of Intensive Care Medicine
Hôpital Universitaire Taher Sfar