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

RecruitingNAAges 40 Years - anyAllHôpital Universitaire Taher Sfar
NCT07842510 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 mechanic

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📋 Eligibility rules (as published)
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
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What it tests

  • Controlled oxygen therapy
  • Standard oxygen therapy
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Where

2 sites
Taher Sfar Mahdia Hospital
Mahdia, Tunisia
Dhouha Ben Braiek
Kairouan, Tunisia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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