An interventional study of Controlled oxygen therapy and Standard oxygen therapy in Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of COPD and Intensive Care Unit (ICU), sponsored by Hôpital Universitaire Taher Sfar. Recruiting at 2 sites in Tunisia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Hôpital Universitaire Taher Sfar · Not applicable, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 240 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Hôpital Universitaire Taher Sfar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%).
Other: Controlled oxygen therapy
Standard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ \>94%.
Other: Standard 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%.
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%.
Total duration of mechanical ventilation
Total cumulative duration of mechanical ventilation, defined as the sum of the duration of non-invasive ventilation and invasive mechanical ventilation.
Time frame: From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization
Mortality at Day 28
Time frame: Day 28 after randomization
Length of stay in the intensive care unit
Time frame: From randomization until ICU discharge or death, up to 28 days
Requirement for invasive mechanical ventilation
Time frame: From randomization until ICU discharge or death
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pulmonary Disease, Chronic Obstructive →
Hôpital Universitaire Taher Sfar