NCT07842510 Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD
| NCT ID | NCT07842510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital Universitaire Taher Sfar |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2026-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07842510 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07842510 currently recruiting?
Yes, NCT07842510 is actively recruiting participants. Contact the research team at nouirahajer@gmail.com for enrollment information.
Where is the NCT07842510 trial being conducted?
This trial is being conducted at Mahdia, Tunisia, Kairouan, Tunisia.
Who is sponsoring the NCT07842510 clinical trial?
NCT07842510 is sponsored by Hôpital Universitaire Taher Sfar. The trial plans to enroll 240 participants.
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