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RECRUITING
NCT07842510
NA

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

Sponsor: Hôpital Universitaire Taher Sfar

View on ClinicalTrials.gov

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

Interventions

OTHER

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%.

OTHER

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