Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Tunisia
Dhouha Ben Braiek
NOT_YET_RECRUITING
Kairouan
Taher Sfar Mahdia Hospital
RECRUITING
Mahdia
Contact Information
Primary
Hajer Nouira
nouirahajer@gmail.com
+21622858699
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 240
Treatments
Experimental: Controlled oxygen therapy group
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%).
Active_comparator: Standard oxygen therapy group:
Standard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ \>94%.
Sponsors
Leads: Hôpital Universitaire Taher Sfar

This content was sourced from clinicaltrials.gov