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Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD
Sponsor: Hôpital Universitaire Taher Sfar
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.
Official title: Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-01-01
Completion Date
2028-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Controlled 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%.
Standard oxygen therapy
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%.
Locations (2)
Taher Sfar Mahdia Hospital
Mahdia, Mahdia Governorate, Tunisia
Dhouha Ben Braiek
Kairouan, Tunisia