Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD
Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Exacerbation of COPD
- Intensive Care Unit (ICU)
- Controlled Oxygen Therapy
- Mechanical Ventilation Complication
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Hôpital Universitaire Taher Sfar
- Enrolment target
- 240
- Started
- 1 January 2026
- Main results due
- 1 January 2027
- Study sites
- 2
- Registry updated
- 25 September 2026
Can you take part?
- Aged 40 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(2)
Taher Sfar Mahdia Hospital
Mahdia, Mahdia Governorate, Tunisia
Recruiting
Dhouha Ben Braiek
Kairouan, Tunisia
Not yet recruiting
Showing 2 of 2 sites. 1 of the 2 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07842510. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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