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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorHôpital Universitaire Taher Sfar

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Controlled oxygen therapy

    Other intervention

    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

    Other intervention

    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%.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Controlled oxygen therapy groupExperimental treatment 1 intervention
Group B: Standard oxygen therapy group:Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Mortality at Day 28

Time frame
Day 28 after randomization
2

Length of stay in the intensive care unit

Time frame
From randomization until ICU discharge or death, up to 28 days
3

Requirement for invasive mechanical ventilation

Time frame
From randomization until ICU discharge or death

Other outcomes

Sponsors and contacts

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